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
VP
Anne Tingsgård holds a Master of Pharmacy degree and joined KLIFO in September 2014. She has more than 30 years’ regulatory affairs experience from both big pharma and private consulting, including two years as CEO and COO in A-consult.
Direct/mobile: +45 44 222 940
Email: moc.ofilk@draagsgnit.enna
Expertise &
therapy areas
Expertise:
KLIFO Regulatory Affairs Solutions have an expert end to end understanding of all your regulatory needs:
- Consultancy services – Recommendation and writing of regulatory strategies and solutions
- 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, 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, HQ RA & Affiliate RA tasks
