INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Tips For Your Virtual Meetings With The FDA

  It seems unlikely that the FDA will return to in-person meetings. This author, an FDA veteran, shares tips for pharma, biotech, and medical device companies on many aspects of your virtual meetings with the FDA: optimal timing of your first meeting, the video/teleconference experience, and more.

• FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner

  Last minute, squeaky clean! After years of planning, negotiation, and input, the user fee reauthorization bill was passed and signed into law on the very date that the programs were scheduled to sunset. This article sums up the key takeaways, CBER's reorganization with new product-specific offices, and more.

• 6 Steps To Simplify Software Validation

  Six steps to reducing the time, pain, and expense of the software validation process while maintaining quality and safety.

• Best Practices for Life Science Quality Leaders to Manage and Mitigate Risk

  Learn how to improve traditional risk management methods and tools and how AI can help in the identification and mitigation of risk.

• Cybersecurity And Product Design Of Automated Systems

  Learn about the importance of cybersecurity for automated equipment, it's weaknesses and risks, and how to mitigate for them by sensible practice and good system design.

• Achieving Next-Level Quality With Digital Technology In Manufacturing

  Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

• Medical And Regulatory Consulting

  Novotech’s medical and regulatory consulting team offers full range of pre-clinical, regulatory affairs support, medical and pharmacovigilance consulting services.

• Life Sciences RIM: Modernization & Moving Ahead

  Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.

• Applying Quality System Regulation (QSR) Best Practices To Improve Regulatory Compliance

  QSR compliance can be complex, but it doesn’t have to be burdensome. Implementing these best practices will improve your regulatory compliance while producing a product ready for market.

• Compliance And Validation Services For Waters Informatics Solutions

  We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.