Regulatory Strategy | Generics | Hybrids | Biologicals | Rare Diseases | Unmet Medical Need | Orphan Drug Designations | Paediatric Strategy | PIP Deferrals/Waivers | Marketing Authorisation Applications | CMC Module 3 and 2.3 | Pre and Post Approval Support | Submission Management | Due Diligence/ Gap Analysis | Scientific and Technical Writing | Response to Questions/RtQ/RSI | Compilation of Dossiers | Full/Partial Module 1-5 Preparation | eCTD Publishing | User Testing of Leaflets | Centralised, MR-DC and National procedures | Simple, Complex, Grouped and Worksharing Variations | Renewals | Sunset Clause | MA Transfers/Change of Ownership | Medical Information Services | In-out licensing (share product list) | Co-development | Divestment opportunities | CEP/TSE Updates & more!

We work in collaboration with our Network Partners ranging from Consulting Companies, Freelance/ Independent SME’s and companies of varying sizes meaning sky is the limit! Feel free to contact us if services you require are not listed here and we will endeavour to match your needs.