• 3 CMC Mistakes That Could Cost You Billions

    The end game for many small biotech startups is acquisition by Big Pharma. How should small biotech companies prepare their chemistry, manufacturing, and controls (CMC) documentation for due diligence review? What are the mile markers that measure how far product and process have developed? While the CMC section may not add zeros to the sales price, poorly documented development can remove them.

  • Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away

    Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

  • When Should Formal Quality By Design Documentation Begin?

    When is the best time to start quality by design (QbD)? This question is asked most frequently among many small firms. A better way to phrase it is: When should I formally document my QbD activities?

  • Debunking The Top 3 Myths About Quality By Design (QbD)

    Pharmaceutical QbD and quality risk management principles have become mainstays, but prevalent myths stymie adoption of the concepts. Dismantling those myths enables more companies to capitalize on the benefits of QbD.


Kevin Wall

Kevin Wall is principal consultant and owner of Cincero Consulting. He has worked with five virtual pharmaceutical companies to move eight of their drug substance and drug product projects through development. He applies “fit for phase GMP” from Phase 1 to commercialization. Wall’s process for identifying critical quality attributes (CQAs) and critical process parameters (CPPs) forms the basis for the CMC section of the regulatory submission (ICH Q11). He led the Johnson & Johnson development and global deployment of quality by design (ICH Q8) and quality risk management (ICH Q9) in pharmaceutical development and operations. He helped define and deploy Janssen’s risk-based qualification and process validation systems (ICH Q7). You can contact Wall at 817-915-0822 or, or visit his YouTube channel, cGMP Made Easy.