Regulatory Articles. App Notes, Case Studies. & White Papers

  1. Achieving Business Continuity In Pharma During COVID-19 Restrictions 3/4/2021

    To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

  2. Q&A: Achieving BLA Success Using A Structured Approach 1/19/2021

    Drs. Jason Osman and John McGuire from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s structured approach to developing a CMC strategy.

  3. Regulatory Consideration For Biotech Startups 1/15/2021

    The whirlwind of activity emerging biopharma leaders are seeing for the first time isn’t entirely uncharted territory. Several startup veterans share insight and inspiration on clinical-stage regulatory considerations.

  4. Best Practices Guide To Data Privacy In Clinical Trials 1/6/2021

    As life sciences companies grow, so do the regulatory compliance requirements. These responsibilities extend beyond conventional health-related frameworks and into the realm of data privacy as well.

  5. 3 Ways To Survive The Shifts In Life Sciences 1/6/2021

    Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.

  6. 3 Ways To Mitigate Data Manipulation Risk In Drug Development 1/6/2021

    A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

  7. Why Life Sciences Needs The Science Of Security 1/6/2021

    Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.

  8. Success At Speed: Best Practices To Accelerate Vaccine Development 12/18/2020

    This collection of articles documents each step in the vaccine development journey and how technology and partnerships make the difference in getting medicines to patients when they need them most.

  9. Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter 12/10/2020

    Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. Learn how the advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.

  10. Top 5 Risks That Can Compromise Your Life Sciences Data 12/10/2020

    Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.