Biosimilar Regulatory solution center

  1. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

    As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

  2. AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance 6/4/2024

    This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.

  3. Is Your Intellectual Property Safe With Indian CROs And CDMOs? 6/3/2024

    Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.

  4. EMA Updates Guidance On Inhalation And Nasal Product Quality 5/29/2024

    The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.

  5. A Synergy Of Excellence: Partnership During Unprecedented Times 5/28/2024

    Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

  6. Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024

    The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.

  7. New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies 5/16/2024

    The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.

  8. Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations 5/6/2024

    Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.

  9. Strategies For Ensuring Virus Bank Manufacturing Success 4/29/2024

    Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.

  10. Integrating Quality Processes And Documentation After A Merger 4/25/2024

    If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.