Category: EIN Presswire

  • Telly and Amlogic Partner to Power the First AI-Ready, Dual-Screen Television Platform Built for the Connected Home

    LOS ANGELES, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Telly, the smartest TV ever built and offered at the revolutionary price of free, today announced a strategic partnership with Amlogic to power its advanced computing architecture with one of the most powerful system-on-chip (SoC) platforms ever used in a consumer television.

    While traditional “smart” TVs are built on commodity chipsets optimized only for multimedia performance, Telly was engineered from the ground up as a true next-generation platform for the connected home. Powered by Amlogic’s eight-core processor with dedicated neural processing, Telly delivers more than twice the performance of typical TV chips, enabling new classes of AI-driven experiences, motion-tracking fitness, gaming, shoppable media, advanced interactivity, and a persistent smart-home control layer that replaces multiple devices.

    “Our goal wasn’t to just build a better TV, it was to invent an entirely new platform for the connected home,” said Sascha Prueter, Telly Chief Product Officer. “To do that, we needed a processor architecture capable of far greater compute capability, richer peripheral support, and advanced AI performance, and Amlogic delivered. Our technology stack enables Telly to run complex applications and neural-driven services that simply aren’t possible on traditional TV chipsets.”

    With consumers increasingly expecting their screens to act as intelligent surfaces connected to their broader digital lives, Telly’s advanced silicon foundation positions it as a category leader for future AIoT experiences.
    This processing power allows Telly to drive simultaneous 4K video on its main display and dynamic information, apps, and interactivity on its second screen, while supporting industry-leading audio performance with more independent audio pipelines than any other TV on the market, enabling separate volume controls, dual-source playback, and real-time audio mixing.

    “Traditional smart TVs simply aren’t smart. They were never engineered to process complex applications or act as true computing platforms,” added Telly’s Prueter. “Our neural-enabled chipset lets us do what no other TV can – drive two displays, advanced audio, real-time interactivity, and AI-powered applications simultaneously. This technology forward approach ensures Telly remains the smartest, most future-ready TV platform ever built.”

    James Xie, Senior Vice President of Corporate Business Strategy at Amlogic, commented, “Amlogic is proud to partner with Telly in building their breakthrough platform with Amlogic’s advanced AI processor. Amlogic SoC’s powerful compute architecture, along with the built-in NN engine, enables Telly’s vision for an AI-powered home hub capable of running complex applications, interactive media, and next-gen services beyond the traditional TVs.”

    About Telly

    Telly is the smartest TV ever built—offered at the revolutionary price of free. Reserve yours today at www.telly.com and see why the living room will never be the same.

    About Amlogic

    Amlogic is a world-leading fabless semiconductor company that specializes in the design, development, and application of high-intelligence system-on-chips (SoCs). As a result of its cutting-edge technologies and best-in-class solutions, the company has actively expanded into new areas including edge AI processors, wireless connectivity, and automotive electronics — ushering in a new era of smart living. By providing complete turnkey solutions in combination with industry-leading software and hardware technologies — including multimedia processing, AI accelerators, state-of-the-art security systems, and advanced CPUs and GPUs — customers can rapidly optimize and develop market-leading products with world-class performance.
    Amlogic is dedicated to sustainability and implements state-of-the-art silicon processing techniques along with advanced power management solutions. Founded in Silicon Valley, Amlogic has R&D, support, and sales offices worldwide. Learn more www.amlogic.com

    Press Contact
    Telly
    dallas@telly.com

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  • Jon ‘Money Mase’ Mason Empowers New Salespeople to Achieve Early Success

    ORLANDO, FL, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Jon “Money Mase” Mason, nationally recognized sales trainer, entrepreneur, and leadership coach, is helping a new generation of sales professionals achieve success from the very beginning of their careers through his results driven training programs. At a time when many new salespeople struggle to gain traction, Mason’s methodology focuses on accelerating performance, building confidence, and enabling participants to generate income early rather than waiting months for results.

    Entering the sales profession can be daunting. New hires often face steep expectations, unfamiliar processes, and the pressure to produce revenue without a clear roadmap for doing so. Mason’s programs address this challenge directly by providing structured systems that transform prospecting and selling into repeatable, learnable skills.

    “Early wins change everything,” Mason said. “When new sales professionals see results quickly, they develop belief in themselves and in the process. That belief drives activity, and activity drives long term success.”
    Central to Mason’s approach is the concept of disciplined prospecting. Rather than treating outreach as an unpredictable art, he teaches it as a systematic process grounded in daily action. Participants learn how to identify qualified prospects, initiate meaningful conversations, handle objections with confidence, and guide prospects toward decisions without relying on high pressure tactics.
    M
    ason emphasizes authenticity and relationship building as key drivers of sustainable performance. His training moves beyond rigid scripts, encouraging professionals to communicate clearly, listen actively, and position themselves as trusted advisors rather than transactional sellers. This approach not only improves conversion rates but also fosters long term client relationships.

    Another critical component of the program is mindset development. Rejection, uncertainty, and performance pressure can quickly derail newcomers. Mason equips participants with tools to manage setbacks, maintain focus, and develop resilience. By reframing challenges as opportunities for growth, new salespeople learn to persist through obstacles that might otherwise cause them to leave the profession.
    The training is highly practical and application focused. Workshops incorporate real world scenarios, role playing exercises, and immediate implementation strategies so participants can apply what they learn right away. This hands on format ensures that individuals leave with actionable skills rather than theoretical knowledge.

    Organizations that implement Mason’s methodology often experience faster onboarding timelines and improved retention. When new hires begin producing revenue sooner, morale increases across teams and the overall cost of training decreases. Leaders also gain structured frameworks for coaching, accountability, and performance measurement.

    In addition to individual contributors, Mason provides guidance for sales managers seeking to build high performing cultures. His leadership insights emphasize clear expectations, measurable activity standards, and consistent support. By aligning team behavior with proven processes, organizations can create sustainable growth rather than relying on sporadic high performers.

    Mason’s impact extends across industries including financial services, real estate, technology, professional services, and business to business sales. His programs are delivered through live events, corporate training sessions, keynote presentations, and ongoing coaching engagements tailored to each client’s objectives.
    The demand for effective sales training continues to rise as businesses face increased competition and evolving buyer behavior. Decision makers are more informed than ever, making disciplined outreach and authentic communication essential for success. Mason’s framework equips professionals with the tools needed to stand out in this environment.

    “Sales is one of the most powerful skills a person can develop,” Mason added. “When individuals learn how to create value, communicate effectively, and serve clients at a high level, they unlock opportunities that can transform their lives.”

    About Jon “Money Mase” Mason
    Jon “Money Mase” Mason is an entrepreneur, author, sales trainer, and leadership coach known for helping individuals and organizations build predictable pipelines and close deals with confidence. Through his signature training programs, he equips professionals with the skills, discipline, and mindset required to achieve consistent high performance.

    Jon Mason
    LMT Financial
    +1 954-461-3009
    email us here
    Visit us on social media:
    Instagram

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  • Introducing Psychological Evaluations for Immigrants From Pro Psychological Analysis

    BOYNTON BEACH, FL, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Pro Psychological Analysis, a professional provider of clinical assessment services, is introducing specialized psychological evaluations designed to support immigrants navigating complex legal processes. These services are structured to assist immigration attorneys and applicants who require detailed psychological documentation as part of asylum claims and extreme hardship waivers.

    Psychological evaluations play a critical role in immigration cases by providing objective, clinical insight into emotional, cognitive, and psychological factors that may affect an individual or their qualifying family members. In asylum cases, evaluations help document trauma-related symptoms, emotional distress, and long-term psychological impact tied to persecution or fear of return. These assessments are carefully prepared to align with legal standards and support immigration filings with clear, evidence-based findings.

    For cases involving extreme hardship waivers, Pro Psychological Analysis conducts evaluations that assess the emotional and psychological consequences a qualifying relative may face if separation occurs. These reports are commonly used to support waiver applications by illustrating the depth and severity of hardship in a professional, clinically sound manner. Each evaluation is completed with attention to accuracy, clarity, and legal relevance.

    Pro Psychological Analysis works closely with legal professionals to ensure psychological evaluations are thorough, confidential, and compliant with applicable ethical and clinical guidelines. The firm’s approach emphasizes neutrality, professionalism, and detailed reporting, offering immigration attorneys reliable documentation to strengthen case presentation.

    Please visit Pro Psychological Analysis’s website for more information about psychological evaluations for immigration matters, including support for asylum claims and extreme hardship waivers.

    About Pro Psychological Analysis
    Pro Psychological Analysis provides comprehensive psychological evaluation services tailored to immigration-related legal needs. The practice is dedicated to delivering high-quality, ethically sound assessments that assist attorneys and individuals in presenting well-supported immigration cases across the United States.

    Media Contact:
    Content Editor
    Website: https://ppanalysis.com/

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  • Tax Expert Launches Free AI Tax Assistant Backed by Actual IRS Code for Small Business Owners

    TaxForge delivers plain-English tax answers citing real IRC sections and IRS Publications built by a Fortune-level corporate Tax Expert

    NEW YORK CITY, NY, UNITED STATES, March 17, 2026 /EINPresswire.com/ — KKATC today announced the launch of TaxForge, a free AI-powered tax assistant designed specifically for small business owners, freelancers, and sole proprietors. Unlike generic AI tools that generate unverified tax guidance, TaxForge grounds every answer in authoritative sources including IRS Publications, Internal Revenue Code sections, Treasury Regulations, and Big 4 firm guidance.

    TaxForge was built by Konstantin Koretskiy, a corporate tax expert with Fortune-level experience, in response to a recurring problem: small business owners were paying for professional consultations or relying on generic AI answers for questions that have clear, citable answers in the IRS code.

    “Small business owners deserve the same quality of tax information that Fortune-level corporations have access to,” said Koretskiy. “TaxForge doesn’t guess. It cites the actual IRS publication number and IRC section so small business owners know where the answer comes from – and can verify it with their own Tax advisor.”

    TaxForge covers the most common small business tax questions including Schedule C deductions, home office rules, quarterly estimated taxes, vehicle and mileage deductions, Section 179 expensing, self-employment tax, and the hobby vs. business distinction for side income operations including card resale and freelance work.

    The tool is free to use with three questions per day. TaxForge Pro unlocks a three-layer response format: the exact IRC source code and legal authority behind every answer, a plain-English breakdown written for non-accountants, and a “What This Means For You” section with practical guidance for small business owners. TaxForge Pro starts at $19.99/month with no contracts. TaxForge enforces a strict use policy and includes a permanent ban system for misuse – the tool is designed for tax education and compliance, not tax evasion.

    TaxForge is available now at kkatc.com/taxforge. No account required to start.

    About KKATC
    KKATC is an AI tools company founded by Konstantin Koretskiy, a corporate tax expert with Fortune-level experience. The KKATC suite builds focused AI tools for entrepreneurs and small business owners. TaxForge is the flagship product. Learn more at kkatc.com.

    KONSTANTIN KORETSKIY
    KKATC
    +1 718-314-6035
    email us here
    Visit us on social media:
    Instagram
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  • Qalitex Laboratories Offers GMP Consulting for 21 CFR Part 111 Quality System Development

    GMP Consulting Supports FDA Audits, SOPs, Testing, and GMP Readiness for Supplement Manufacturers

    IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited testing laboratory with GMP consulting capabilities serving dietary supplement manufacturers across California and North America, today outlined the core components of a 21 CFR Part 111-compliant quality system and common gaps identified during FDA cGMP inspections.

    FDA’s current Good Manufacturing Practice regulations for dietary supplements, codified in 21 CFR Part 111, set minimum quality standards that all supplement manufacturers must meet. The regulations cover facility design, equipment qualification, raw material testing, in-process controls, finished product testing, batch record documentation, and complaint handling. Compliance applies to all manufacturers, including contract manufacturers, private label brands, and importers.

    Inspection data shows recurring cGMP violations in supplement manufacturing facilities. Common observations include:

    Incomplete or outdated written procedures for laboratory operations

    Failure to conduct identity testing on all incoming ingredients

    Inadequate batch production records

    Lack of established specifications for raw materials and finished products

    “The pattern we see most often is a manufacturer has a quality system on paper that looks complete, but the written procedures don’t reflect what happens on the floor,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “FDA investigators identify that gap quickly. A mock audit is valuable because it tests both documentation and practice, giving manufacturers time to address gaps before an actual inspection.”

    Qalitex’s GMP Consulting Program begins with a cGMP gap analysis, evaluating the manufacturer’s existing quality system against 21 CFR Part 111, identifying deficiencies, and prioritizing corrective actions by regulatory risk. This is followed by a mock FDA inspection, conducted using FDA protocols, with a written report detailing observations and recommended corrective actions.

    A core component of the program is SOP development. Qalitex provides a library of 21 CFR Part 111-compliant SOP templates covering laboratory operations, raw material receiving and testing, in-process controls, finished product testing, batch record documentation, equipment cleaning and maintenance, environmental monitoring, and complaint handling. SOPs are customized to the manufacturer’s operations and aligned with current FDA expectations.

    For manufacturers seeking NSF GMP certification — a third-party program recognized by major retailers and Amazon — Qalitex’s GMP Consulting Program includes pre-assessment mock audits and corrective action support. Retailers including Whole Foods Market, Costco, and Target require GMP certification or equivalent documentation from supplement suppliers.

    “Brands that invest in their quality systems proactively can respond quickly when retailers or Amazon request compliance documentation,” said Abochama. “Brands that wait until a problem arises spend significantly more time and resources correcting issues. A well-designed quality system is a competitive advantage, enabling brands to meet regulatory and retailer expectations efficiently.”

    Resources:
    Full article: https://qalitex.com/services/gmp-consulting/

    About Qalitex Laboratories
    Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.

    Nour Abochama
    Qalitex Laboratories
    +1 949-881-6661
    email us here
    Visit us on social media:
    LinkedIn
    Instagram
    Facebook

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  • Omen Kaine’s ‘The Heart Tells Tales’ Breakout Theatrical Hit Expands into Film and International Jazz Musical Adaptation

    Omen Kaine’s The Heart Tells Tales A Runaway Hit!

    The highest order of beauty, is the divine of chaos.”
    — Omen Kaine

    BROOKLYN, NY, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Playwright and creator Omen Kaine is captivating audiences and critics alike as his bold and emotionally charged stage production, The Heart Tells Tales, emerges as one of the most talked-about new works in contemporary theater. Following sold-out runs in Los Angeles and New York, Kaine’s acclaimed production is now expanding into film development and an international jazz musical adaptation, signaling the rapid rise of a distinctive new voice in theater and storytelling.

    The Heart Tells Tales premiered at the Skiptown Theater in Los Angeles in November 2025, featuring leads Danny Hackin and Fred Thomas, with Ashley Kay, Jenn Brown, Kat Johnston and Justin Vanhpraseuth rounding out the ensemble. The production sold out every performance, driven by powerful word-of-mouth and passionate audience response.

    Building on that momentum, the production moved to New York’s Under St. Marks Theater, with a new cast led by Matthew Conkling, Pierce Bunch, and Dewitt Gilmore, supported by Felica Nadine, Paige Noelle, Bonnie Schneider, Joseph Dalton, and Janna Bastone. The New York engagement replicated the same box-office success, earning critical acclaim and expanding The Heart Tells Tales’ reputation as a must-see theatrical experience.

    Expansion into Film and Music
    Kaine’s production company, Hi Fi Underground Productions, has begun development on a cinematic adaptation of The Heart Tells Tales, produced by Jonathan Henderson and Ruben Anavitate. The project marks the first step in bringing Kaine’s theatrical world to the screen.

    Meanwhile, across the Atlantic, an innovative jazz musical adaptation is in negotiation in Brussels, Belgium, with Stephane Mercier—an acclaimed saxophonist and Berklee College of Music graduate—and his son, keyboardist Mael Idris, both of the Clandestine Circle Quintet. This new version aims to transform the play’s emotional depth into a dynamic and soulful jazz performance.

    The adaptation is also being considered for inclusion in the 2026 Théâtre Marni Jazz Festival, with growing interest from multiple European venues.

    National and International Attention
    With its bold storytelling and cross-medium expansion, Kaine’s work is drawing increasing national media attention. A recent feature in the NY Daily News highlights his ambition to create an interconnected creative universe spanning theater, film, and music.

    Read the full article here: https://www.nydailynews.com/2026/03/12/omen-kaine-is-building-a-universe-and-audiences-are-starting-to-pay-attention/

    About Omen Kaine
Omen Kaine is a playwright, director, and founder of Hi Fi Underground Productions, dedicated to developing original works that push artistic boundaries across stage, film, and music.

    Media Contact:
Hi Fi Underground Productions
    Press Office
Email: hifiunderground93@gmail.com

    Omen kaine
    Hi Fi Underground
    hifiunderground93@gmail.com
    Visit us on social media:
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    SOLD OUT The Heart Tells Tales LA Shows!!!

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  • To Steal A Moment’s Time Reveals A Mother’s Wartime Diary Of Courage, Survival, And Hope

    G. J. Berger presents the remarkable diary of Katharina Berger, capturing a mother’s experience raising a child amid the chaos of World War II.

    NEW YORK CITY, NY, UNITED STATES, March 17, 2026 /EINPresswire.com/ — A powerful historical memoir is bringing readers into the intimate and often overlooked experiences of civilians living through one of the most devastating periods in modern history. To Steal a Moment’s Time, by Katharina Berger and G. J. Berger, presents a remarkable collection of diary entries written during the final years of World War II, offering a deeply personal account of survival, motherhood, and resilience. The memoir also includes several stunning photographs that further bring these moments to life, giving readers a visual connection to the people and places behind the story.

    On the brink of the war’s most destructive years, Katharina Berger was one of Germany’s most sought-after stage and film actresses. While many artists and colleagues fled the growing danger under Hitler’s regime, Berger remained in her homeland. In 1944, during the height of conflict and uncertainty, she gave birth to a son and began documenting the fragile, unpredictable world surrounding them.

    The diaries that form To Steal a Moment’s Time capture the quiet but powerful determination of a mother determined to protect her child amid chaos. Written during stolen moments of time throughout her son’s first year of life, the entries reveal daily struggles for food, safety, and shelter while war closed in around them. Berger also recounts moments of courage and humanity, including efforts to help Jewish individuals escape persecution during one of history’s darkest chapters.

    At the heart of the memoir is a mother’s hope that her child might one day grow up in a better world. The diary entries reflect both fear and resilience as Berger searched for her missing husband while navigating the uncertainty of wartime Germany. Her reflections capture the emotional weight of living through a war she never supported, offering a rare and deeply human perspective on a historical era often told through broader political narratives.

    Through the careful preservation and presentation of these journals, G. J. Berger brings Katharina Berger’s voice to modern readers. The memoir provides a unique window into everyday life during wartime and highlights the strength of individuals who endured unimaginable hardship while holding on to hope for the future.

    Kirkus Reviews has offered strong praise for the work, noting: “This work is a rare feat, a seamless amalgam of an unflinching literary realism with an unsentimental affirmation of life. A beautiful war account—both unsettling and inspiring.”

    Written for readers interested in history, memoir, and stories of human resilience, To Steal a Moment’s Time stands as a moving reminder of the courage found in ordinary lives during extraordinary times.

    G. J. Berger is a writer dedicated to preserving and sharing meaningful historical narratives. Through the publication of Katharina Berger’s wartime diaries, the work helps ensure that personal stories of courage, compassion, and perseverance continue to be remembered by future generations.

    The book is now available—secure your copy here: https://a.co/d/01WOaFMF

    For review copies, interview requests, or additional information, please contact:

    G. J. Berger
    BrightKey PR
    +1 (646) 640-0262
    gjberger@hotmail.com

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  • Qalitex Laboratories Achieves ISO 17025 Accreditation for Analytical Testing

    A2LA-accredited Irvine lab explains why accredited vs. self-declared compliance determines COA acceptance by Amazon, retailers, and FDA.

    IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party testing laboratory with facilities in Irvine and San Diego, California, today shared expert insights on what ISO/IEC 17025:2017 accreditation requires and why the distinction between accredited and non-accredited testing matters for dietary supplement brands, cosmetic companies, and Amazon FBA sellers navigating FDA compliance and retailer qualification requirements.

    ISO/IEC 17025:2017 is the international standard for testing and calibration laboratory competence, published by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). Accreditation to this standard is granted only after an independent body — in the U.S., typically A2LA (American Association for Laboratory Accreditation) or ANAB (ANSI National Accreditation Board) — conducts a rigorous on-site technical assessment of personnel qualifications, equipment calibration records, test method validation, quality management systems, and proficiency testing participation. Accreditation is not a self-declaration; it is independently verified and publicly searchable.

    For supplement and cosmetic brands, ISO 17025 accreditation has practical significance: Amazon compliance programs, major retailers such as Whole Foods Market and Target, and FDA import alert requirements all reference ISO 17025 accreditation as the benchmark for acceptable third-party testing documentation. Certificates of Analysis (COAs) from non-accredited labs may not meet these standards, regardless of internal quality claims.

    “The question we get most often from new clients is whether their current lab is truly ISO 17025 accredited or simply claims compliance,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “Compliance means the lab says it follows the standard. Accreditation means an independent body verified it does. Anyone can check our A2LA accreditation number in about 30 seconds, and we encourage every brand to do the same for any lab they work with — including ours.”

    ISO 17025:2017 requirements are divided into management requirements — covering quality management systems, document control, and corrective actions — and technical requirements, which address personnel competence, equipment calibration, measurement traceability, test method validation, and proper handling of test items. Accreditation scope matters as much as status: a lab may be accredited for water testing but not for heavy metals, microbiology, or other critical methods. Brands should confirm that a laboratory’s accreditation explicitly covers the methods required for their products.

    Qalitex’s A2LA accreditation covers analytical chemistry, including HPLC identity and potency testing, ICP-MS heavy metal analysis per USP , GC-MS and LC-MS/MS pesticide residue testing, microbiology per USP and , preservative efficacy per USP and ISO 11930, and ICH Q1A(R2)-compliant stability testing. The laboratory serves brands from raw material inspection through finished product release, with 48-hour turnaround on standard analytical panels.

    Recent regulatory developments have made accreditation increasingly critical. FDA enforcement of 21 CFR Part 111 cGMP regulations requires identity verification of all incoming raw materials. For cosmetics, the Modernization of Cosmetics Regulation Act (MoCRA), effective 2024, mandates safety substantiation from qualified, accredited laboratories.

    “The brands we see after an Amazon compliance hold or retailer audit often already have testing documentation — but from labs whose accreditation does not cover the specific methods used,” said Abochama. “It’s not that they weren’t trying to comply; the difference between an accredited and a non-accredited method isn’t always obvious from a COA. Part of our onboarding process is reviewing existing documentation and identifying gaps before they become regulatory issues.”

    Brands can verify laboratory accreditation at a2la.org
    and anab.org
    , both of which allow searches by laboratory name, location, and accreditation scope. Qalitex’s A2LA accreditation details, including scope and certificate, are publicly available in the A2LA directory.

    Resources:
    Full article: https://qalitex.com/iso-17025-accredited-laboratory/

    About Qalitex Laboratories
    Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.

    Nour Abochama
    Qalitex Laboratories
    email us here
    Visit us on social media:
    LinkedIn
    Instagram
    Facebook

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  • Qalitex Laboratories Launches Regulatory Consulting for Supplement and Pharma Brands

    ISO 17025 Lab Provides FDA, GMP, and Amazon Compliance Support for Supplement & Pharma Brands

    IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited testing laboratory offering regulatory consulting services for supplement and pharmaceutical brands across North America, today addressed the growing FDA regulatory compliance challenges that dietary supplement manufacturers and pharmaceutical developers face in 2026 — including increased inspection frequency, expanded import alert coverage, and the growing complexity of Amazon compliance documentation requirements.

    FDA’s enforcement posture toward dietary supplement manufacturers has intensified over the past several years. The agency has increased the frequency of cGMP inspections for dietary supplement facilities, and a significant percentage of inspections result in Form 483 observations — written notices identifying conditions that may constitute violations of the Food, Drug, and Cosmetic Act. The most commonly cited violations involve failures in identity testing for incoming raw materials, inadequate batch production records, and missing or insufficient written laboratory procedures.

    For pharmaceutical developers, the regulatory landscape presents different but equally complex challenges. IND application CMC sections require stability data, analytical method validation packages, and manufacturing process descriptions that meet FDA’s current expectations, which have evolved with new guidance on elemental impurities (ICH Q3D), nitrosamine impurities, and drug substance characterization.

    “What we see most often when a brand comes to us after receiving a Form 483 or warning letter is that the underlying issue was a quality system gap present for some time,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “The inspection just made it visible. Our regulatory consulting work focuses on helping brands find and close those gaps before an inspection — not after. A mock audit conducted six months before an FDA inspection is far more valuable than a warning letter response written six weeks afterward.”

    Qalitex’s regulatory consulting practice includes:

    FDA warning letter response strategy and corrective action planning

    cGMP gap analysis against 21 CFR Part 111 (dietary supplements) and 21 CFR Part 211 (pharmaceuticals)

    Mock FDA inspection services with written reports and prioritized corrective action recommendations

    SOP library development and review

    Product label review and structure/function claims analysis

    Health Canada NHP regulatory support for brands seeking Canadian market entry

    For Amazon FBA sellers, regulatory compliance has taken on new dimensions as Amazon has expanded documentation requirements for supplements and cosmetics. Seller Central compliance programs now require Certificates of Analysis from ISO-accredited laboratories, heavy metal testing documentation, microbiology reports, and, in some categories, stability data. Sellers unable to provide compliant documentation risk listing suspension, account holds, and inventory removal.

    The combination of laboratory testing and regulatory consulting provides a significant advantage for brands working with Qalitex. When regulatory consulting identifies a need for specific testing data — whether for an FDA response, retailer audit, or Amazon compliance hold — testing can be initiated immediately within the same organization, with results integrated directly into the regulatory response.

    “The brands that navigate FDA compliance most successfully are the ones that treat it as a quality system investment rather than a compliance checkbox,” said Nour Abochama. “When we conduct a mock audit, we don’t just report violations — we identify the gaps an FDA investigator would find so the brand can address them proactively. That preparation makes a real difference.”

    Resources:
    Full article: https://qalitex.com/services/regulatory-consulting/

    About Qalitex Laboratories
    Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.

    Nour Abochama
    Qalitex Laboratories
    +1 949-881-6661
    email us here
    Visit us on social media:
    LinkedIn
    Instagram
    Facebook

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    EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
    for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
    article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

  • Qalitex Laboratories Expands Pharmaceutical Testing Services for Drug Developers and CROs

    ISO 17025-accredited California lab offers HPLC, LC-MS/MS, ICP-MS, and ICH stability studies with 48-hour turnaround for FDA submissions.

    IRVINE, CA, UNITED STATES, March 17, 2026 /EINPresswire.com/ — Qalitex Laboratories, an ISO 17025-accredited third-party analytical testing laboratory serving pharmaceutical developers, contract research organizations (CROs), and dietary supplement brands across North America, today highlighted the pharmaceutical testing requirements that drug developers and small biotechs must address when preparing IND and NDA submissions to the FDA — and how analytical chemistry testing, stability studies, and method validation integrate into the regulatory timeline.

    FDA requirements for pharmaceutical analytical testing are governed by ICH guidelines, which define standards for stability testing, method validation, and impurity profiling. ICH Q1A(R2) establishes stability testing requirements for new drug substances and products, including storage conditions, testing intervals, and the data package required for regulatory submissions. ICH Q2(R1) defines validation requirements for analytical procedures, including specificity, linearity, range, accuracy, precision, and detection and quantitation limits.

    For drug developers preparing IND filings, stability data is a mandatory component of the chemistry, manufacturing, and controls (CMC) section. FDA requires data demonstrating that the drug substance and product maintain acceptable quality throughout the proposed shelf life. For early-stage IND submissions, accelerated stability data at 40°C / 75% RH per ICH Q1A(R2) is typically required, with long-term stability studies at 25°C / 60% RH initiated at the time of filing.

    “The challenge for small drug developers and biotechs is that large CROs often have 6-to-12-week wait times for routine analytical testing and stability program initiation,” said Nour Abochama, Vice President of Operations at Qalitex Laboratories. “When you’re working toward an IND filing deadline, that timeline can be a significant constraint. We built our pharmaceutical testing program to provide CRO-quality analytical results — validated methods, ICH-compliant stability chambers, pharmaceutical-grade QC documentation — with turnaround times that align with real development schedules.”

    Qalitex’s pharmaceutical analytical testing capabilities include:

    HPLC and UPLC for identity, potency, and purity

    LC-MS/MS for impurity profiling and trace-level quantitation

    ICP-MS for elemental impurity analysis per ICH Q3D

    GC-MS for residual solvent testing per USP and ICH Q3C

    Dissolution testing per USP

    Content uniformity per USP

    All methods are validated per ICH Q2(R1) or developed against applicable USP monographs.

    Stability testing at Qalitex is conducted in ICH-qualified chambers with continuous temperature and humidity monitoring and automated data logging. The laboratory offers long-term stability at 25°C / 60% RH (ICH Zone II), intermediate at 30°C / 65% RH, and accelerated at 40°C / 75% RH, with testing at ICH-specified time points of 0, 3, 6, 9, 12, 18, 24, and 36 months. Photostability testing per ICH Q1B is also available.

    California’s life sciences sector includes more than 3,000 companies, with a significant concentration of small and mid-size drug developers and biotechs in the San Diego and Los Angeles corridors. Many lack in-house analytical testing infrastructure and rely on contract testing laboratories for both development-stage and commercial-stage analytical work.

    “The questions that matter most when a pharmaceutical developer evaluates a testing laboratory are about method validation and regulatory defensibility,” said Abochama. “Is the method validated for your specific matrix? What reference standards were used? Is the stability chamber ICH-qualified with continuous monitoring? Can you provide the validation data for inclusion in your regulatory submission? We answer these questions directly, and the documentation we provide is designed to be submission-ready.”

    All pharmaceutical testing at Qalitex is performed under FDA 21 CFR Part 211 cGMP guidelines alongside ISO 17025 accreditation standards.

    Resources:
    Full article: https://qalitex.com/services/pharmaceutical-testing/

    About Qalitex Laboratories
    Qalitex Laboratories is an ISO 17025-accredited third-party analytical testing laboratory with facilities in Irvine and San Diego, California. The laboratory provides certificate of analysis (COA) testing, heavy metal analysis by ICP-MS, microbiology testing per USP and , preservative efficacy testing, stability studies under ICH guidelines, and regulatory compliance support for dietary supplement brands, cosmetic companies, and consumer goods manufacturers. Turnaround times start at 48 hours for standard panels. Testing programs meet 21 CFR Part 111, California Proposition 65, Amazon supplement compliance requirements, and Health Canada NHP Directorate standards.

    Nour Abochama
    Qalitex Laboratories
    +1 949-881-6661
    email us here
    Visit us on social media:
    LinkedIn
    Instagram
    Facebook

    Legal Disclaimer:

    EIN Presswire provides this news content “as is” without warranty of any kind. We do not accept any responsibility or liability
    for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this
    article. If you have any complaints or copyright issues related to this article, kindly contact the author above.