Biosimilar Regulatory solution center

  1. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

    With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

  2. A Practical Packaging Components Checklist For Emerging Biotechs 6/20/2024

    A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.

  3. Lifecycle Planning For Containment And Delivery Of Biologics Drug Products 6/20/2024

    Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development.

  4. What Does FDA's Draft Platform Guidance Mean For CGT Companies? 6/17/2024

    Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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 Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies 5/24/2024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