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