Scientific Writing 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 The team • EU / US MAA: All Modules for the Common Technical Documents A team of experienced consultants and (CTDs), including Summaries and Overviews for EU MAA/NDA/BLA, Risk scientific writers with significant experience Management Plans and Product Information/ prescribing information. in the pharmaceutical industry. • Response to question from Regulatory Authorities • Post MAA / Life-cycle management life cycle management: Variations Our clients (pharmaceutical, clinical…): CTD modules updates, Periodic Benefit- From start-ups to global pharma companies Risk Evaluation Reports … with punctual, repetitive or permanent need for support. When work with us? The team can cover any step of the development process, providing Why work with us? consultancy or hands-on operational support. Our team hold a flexible skill set ranging Among our latest missions from development strategy to operational • Writing clinical modules for submission in EU and US execution, as well as leading and managing projects and expertise in CMC, non-clinical • Writing PIPs, ODDs, INDs, IMPDs…and IBs and clinical. They can also work closely with • CMC writing for chemicals and biologics other specialists in BlueReg to provide an integrated development and regulatory service.