Biosimilar Regulatory solution center

  1. Take Action On PFAS To Protect Your Critical Processes 9/18/2025

    PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

  2. Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite 9/18/2025

    FDA Commissioner Marty Makary has promised to end the so-called "double standard" of announced overseas inspections. Does the agency have the resources?

  3. What Are PFAS And How Do They Impact The Biotech Industry? 9/13/2025

    Forever chemicals pose rising health risks and regulatory challenges. Learn how increasing restrictions on fluorinated compounds could reshape manufacturing, packaging, and sustainability strategies.

  4. A Case Study In Continuous Process Verification 9/8/2025

    CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

  5. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  6. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  7. Overcoming Gene Therapy Cost Roadblocks On The Path To Patients 7/23/2025

    Viral vector-based gene therapies are expanding beyond rare diseases to treat larger populations. Discover how innovations in manufacturing are making these life-changing treatments more accessible.

  8. Viral Gene Therapy: Reducing Costs To Improve Patient Access 7/23/2025

    Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.

  9. 3 Key Considerations In Gene Therapy Manufacturing 7/15/2025

    Viral vector-based gene therapies are redefining medicine. As developers navigate uncharted territory, Sybil Danby of Cytiva highlights three critical areas shaping the journey from discovery to patient access.

  10. Preparing For FDA's Expanded Use Of Unannounced Inspections At Foreign Manufacturing Facilities 7/10/2025

    The FDA announced on May 6, 2025, that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. Here are key considerations and actions to take in order to be prepared.