Regulatory Insights

  1. Meeting Diversity Goals Through Smart Trial Design Strategies 11/8/2023

    Delve into strategies for effectively monitoring and reporting progress toward achieving patient diversity objectives.

  2. Regulatory Review Of Promotional Materials 11/8/2023

    Delve into the challenges, objectives, solutions, and achievements of a regulatory review project undertaken by a mid-size pharmaceutical company across the European Union (EU), Asia-Pacific (APAC), Latin America (LATAM), and the Middle East.

  3. Executing Patient-Focused Drug Development (PFDD) 11/2/2023

    Discover why the differences between individuals and diseases are crucial when crafting a clinical development program.

  4. Sponsor Overcomes Hold And Steers Products Through Development 11/2/2023

    Uncover how a small-sized biotech company was able to resolve critical regulatory CMC deficiencies to meet FDA requirements.

  5. Medical Writing Support Relieves A Burdensome Review 11/2/2023

    Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.

  6. Adopt Tech Solutions To Innovate And Streamline Regulatory Services 10/30/2023

    See how transformative technologies like AI and ML augment the regulatory professional workload to ensure compliance, patient accessibility, and rapid timelines for approval for global drug campaigns.

  7. Regulatory Portfolio Management: From Bad To Gold 10/30/2023

    Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.

  8. Fast-Tracking Your Product Development With An IDP 10/30/2023

    Explore how a customized Integrated Development Plan assisted in the removal of guesswork and obstacles from a startup's development roadmap, enabling it to move with speed and remain competitive.

  9. A Successful Pre-IND Enabling Next Stage Of Development 10/30/2023

    Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.

  10. Effective Clinical Evaluation Preparation Enables EU MDR Compliance 10/30/2023

    Uncover how one company was able to ensure that its European products remained on the market through outsourced preparation of high-quality Clinical Evaluation Reports (CERs) for submission to Notified Bodies.