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Medical Writing & Regulatory Affairs

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Partner with the experts of the regulatory environment and seasoned medical writers

From the early phases of development through marketing authorisation, regulatory interactions are essential to your progress and success. These exchanges will not only shape the advancement of your program, but also the value of your asset and your company. When you are planning your development, regulatory affairs is at the start of an exciting journey. At every stage of the development, it is important to partner with experts who understand the regulatory environment and can act as an independent and trusted advisor to your regulatory activities. The regulatory experts of Venn Life Sciences work with you, as an extension of the team throughout the development of your product, safeguarding a swift execution of the regulatory strategy, by providing timely and competent input on any regulatory concern that may arise.

An extension of your team throughout

As the success of drug development programmes depends on the readability and reviewer-friendliness of the documentation, they are supported by our team of seasoned medical writers and experienced technical consultants, all of whom have a scientific or medical background. With their broad experience in the development of documents for different products and therapeutic fields, they deliver clear and well-structured documents in a timely fashion. This contributes to the timely and swift approval of your submissions.

Venn Life Sciences can support you in:

Regulatory Affairs & Medical Writing

  • Development of regulatory strategy
  • Regulatory due diligence and gap analyses
  • Agency interactions with the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and national regulators in Europe, including the development of the briefing book
  • Paediatric Development Plans (including paediatric investigational plans (PIP) for the European Union)
  • Orphan Drug Designation (ODD) applications
  • Response to requests from regulatory authorities
  • Development of regulatory non-clinical documents (IND, Investigators Brochure, non-clinical overview, non-clinical summary)
  • Development of regulatory clinical documents (IND/CTA package, protocols, clinical overview, clinical summary, clinical study reports)
  • Development of regulatory quality/CMC documents (IMPD/IND, Module 3, quality overall summary)
  • Development of safety related documents (e.g., Development Safety Update Reports (DSUR), narratives, Benefit Risk Assessment reports)

Learn more about Medical Writing & Regulatory Affairs

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