Insights On Regulatory Compliance

  1. Rapid Characterization Of Impurities 1/24/2022

    Understand how to manage impurities in drug development with swift isolation, synthesis, and analysis. A client discovered an impurity during ongoing stability studies that exceeded ICH guidelines.

  2. Method Optimization: Assay Development Following Compendial Methods 1/20/2022

    There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

  3. The No. 1 Most Common Problem In FDA GMP Inspections 6/20/2022

    With issues involving quality responsibilities and procedures at the top of the FDA warning list, we uncover where the solution to make this problem a thing of the past.

  4. 5 Answers To FDA Computer System Validation Questions 4/8/2022

    We answer questions regarding the FDA's indication that a risk-based approach is compliant and significantly reduces the burden on life sciences companies.

  5. Improve Sterility Assurance And Data Integrity In A 503B Compounding Pharmacy 9/18/2020

    Learn about implementing automated technologies like robotics to overcome growing issues with sterility assurance and data integrity.

  6. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

    Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

  7. Growing Complex Generic Application Load May Force US FDA Staffing Changes 8/4/2022

    Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.

  8. The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management 6/22/2022

    This brief provides an understanding of the roles corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement, offering a blueprint to help optimized strategies.

  9. The Largest LOE Event In US Pharma History 8/4/2022

    Ahead of the first biosimilar Humira product set to launch in 365 days, this article provides a comprehensive run-down of where biosimilar sponsors stand and the key issues ahead of market formation.

  10. Insights Into The Medical Device Single Audit Program (MDSAP) 4/19/2022

    Learn how the The Medical Device Single Audit Program allows a single regulatory audit to satisfy the requirements of jurisdictions around the world.