Biosimilar Regulatory solution center

1. What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma? 10/9/2025

   Deciding what is good enough to get started can support the mindset of building something without sacrificing quality, functionality, or safety.

2. Import Product Specifications And Drug Registration Testing For China 10/6/2025

   This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

3. What You Should Know About USP's Bioassay Updates 10/2/2025

   The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

4. Automation In The Lab: Lessons From Successes And Setbacks 9/24/2025

   Real-world examples show that, in some labs, manual screenings disappeared altogether, replaced by automated runs that now cover entire departments.

5. A Risk-Based Approach To Plasmid DNA And mRNA Process Development 9/23/2025

   Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

6. 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.

7. 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?

8. 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.

9. 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.

10. 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.