Scientific Writing

We provide flexible solutions or operational platforms to meet your company’s needs from product development, registration through to launch and product maintenance activities.

Our services

  • Pre MAA EU / US: ODD requests, PIP/ PSP, INDs, Scientific advices briefing packages (for National/EMA Scientific Advice, FDA meetings, oral hearings…), Investigator brochures and annual updates, Safety reports (DSURs, IND annual reports), Target Product Profile
  • EU / US MAA: All Modules for the Common Technical Documents (CTDs), including Summaries and Overviews for EU MAA/NDA/BLA, Risk Management Plans and Product Information/ prescribing information.
  • Response to question from Regulatory Authorities
  • Post MAA / Life-cycle management life cycle management: Variations (pharmaceutical, clinical…): CTD modules updates, Periodic Benefit-Risk Evaluation Reports …

Among our latest missions

  • Writing clinical modules for submission in EU and US
  • Writing PIPs, ODDs, INDs, IMPDs…and IBs
  • CMC writing for chemicals and biologics

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