Regulatory Sciences

  1. FDA Regulatory Consulting 8/29/2024

    Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives.

  2. Regulatory Sciences 8/22/2024

    We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

  3. Good Science Presented Well Generates Regulatory Approvals 8/15/2024

    When seeking marketing approval for a pharmaceutical, biotech, or medical device product, high-quality data is essential. Without it, no application—no matter how well-crafted—stands a strong chance of success.

  4. Improving Patient Health And Safety 7/25/2024

    Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

  5. EMA Services: Ensure Regulatory Success 6/5/2024

    Get support for post-authorization regulatory requirements, spanning product launches, management of variations, new indications, line extensions, and ensuring ongoing compliance to uphold your product's regulatory status throughout its lifecycle.

  6. Comparing FDA's Accelerated Approval And EMA's Conditional Marketing Authorization 6/5/2024

    Gain an understanding of how expedited regulatory pathways can shape the development and approval of therapies for critical medical needs.

  7. The Importance Of Responding To FDA 483 Observations 6/5/2024

    Discover how to effectively respond to FDA 483 observations, ensuring regulatory compliance and safeguarding your company's reputation.

  8. Navigating Expedited Regulatory Pathways In Europe 6/5/2024

    By unraveling the complexities of European programs, learn how to significantly enhance your development efforts and reach patients across Europe, the second-largest pharmaceutical market in the world.

  9. Key Steps To Creating A Successful Market Access Strategy 6/5/2024

    Learn how to create a successful market access strategy and navigate the complexities of pricing and reimbursement in Europe.

  10. The Trifecta Of Promotional Review: What Is A PRC And What Do They Do? 6/5/2024

    The mystique of the Promotional Review Committee (PRC) is unveiled – understanding what it is and why you need it is crucial for ensuring a successful promotional review.