Pharmaceutical/BioPharma & Life Sciences

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 | Artwork, PI, 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 | AI/ML| SaMD | CEP/TSE Updates & more!

Tech

Advisory Services on AI integrations in - Drug discovery | Clinical Trials | Manufacturing | Pharmacovigilance | Regulatory strategy and GxP compliance for AI/ML tools under EMA, MHRA, and EU AI Act | Data governance and validation frameworks | Custom Coding/software development for digital health tools | Regulatory Tech (RegTech) | Data-driven solutions | Patient Data Protection | AI Pilot | AI deployment at scale & more!

IP

End-to-end regulatory and IP strategy | AI-enabled tools | Patent Landscaping | Filings | Freedom-to-operate assessments | Data/market exclusivity | Lifecycle Management | Regional/Global Submissions & 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.