Business solution
KLIFO Regulatory Affairs Solutions merge competence and experience to assist you in navigating all regulatory requirements. With our extensive experience in interacting with national and regional agencies, we can support all your regulatory affairs needs, throughout your development process – from defining a regulatory development strategy and offering scientific advice to supporting specific submissions.
Anne Tingsgård
Expertise &
therapy areas
Expertise
KLIFO Regulatory Affairs Solutions have an expert end-to-end understanding of all your regulatory needs:
- Operational services – Compilation, writing, review and submission
- Regulatory capacity – Flexible and competent regulatory resources
- Insourcing and outsourcing
- Consultancy, operational and writing services
- Providing scientific advice support – Europe & US (e.g. protocol assistance, Pre-IND, type C, End-of-Phase 2 meetings)
- Preparing clinical trial applications and amendments (advice, compilation, writing, review, submission and follow-up)
- Preparing your IMPD, IND, Orphan Drug Designation and PIP (advice, writing, compilation, submission, handling during authorities’ assessment)
- Our services include compilation, review, submission, project management, CP, DCP, MRP, NP, IND, HQ RA & Affiliate RA tasks