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 advice briefing packages (for National/EMA Scientific Advice, FDA meetings; and oral hearings), Investigator brochures and annual updates, safety reports (DSURs, IND annual reports); and Target Product Profiles.
EU / US MAA: All Modules for the Common Technical Documents (CTD); including Summaries and Overviews for EU MAA/NDA/BLA, Risk Management Plans and Product Information/ prescribing information.
Response to questions from Regulatory Authorities
Post MAA / Life-cycle management: Variations (pharmaceutical; and clinical): CTD module updates; and Periodic Benefit Risk Evaluation Reports.
Our latest engagements
Writing clinical modules for submission in the EU and the US
Writing PIPs, ODDs, INDs, IMPDs and IBs
CMC writing for chemical and biological products
Contact our experts today
Composed of proven experts from the pharmaceutical industry, our team is ready to answer to your needs in any area of product development, commercialisation and early access programs, and life cycle management