BlueReg is a consultancy organization offering strategic advice and
hands-on outsourcing solutions to life sciences companies through the entire lifecycle of their products.
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