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