You can rely on our regulatory intelligence as well as on the experience and expertise of our consultants for the success of your project. We can provide you with an end-to-end project plan to guide you from the development of your product right through to authorisation and beyond. Some of the services we offer include:
- Due diligence for licensing or investment decision making
- Strategic expert input and regulatory advice (CMC, non-clinical, efficacy
& safety)
- Data assessment, interpretation & positioning
- Advice on global development plans (including Integration of valuebased
payer evidence requirements), Global regulatory strategy and
meetings with regulators or payers
- Scientific writing of regulatory documents (EU & US): Briefing
documents for scientific Advice, Orphan Drug Designation (ODD),
Paediatric Investigation Plan (PIP), IMPD and IND, Clinical study reports,
MAA and NDA/BLA modules, Responses to Agency questions (RTQ)
- Scientific writing of Pharmacovigilance/safety documents: RMP,
DSURs, PBRERs
- Operational support and Regulatory project management for ODD, PIP,
scientific advice, IMPD, IND, CTAs, CSRs, DSURs… (including Regulatory
publishing)
- Development of Client-Customised Operational Platforms
