Regulatory Affairs Services
KLIFO offers regulatory competence and resources within all regulatory areas, from early development to post-marketing activities. Our regulatory consultants have up to more than 30 years’ experience. Whether you require assistance with daily regulatory activities or expert regulatory advice, we can match your needs.
Areas of expertise
Our senior regulatory affairs specialists have much experience in the pharma, biotech and generics industries.
KLIFO Regulatory Affairs Services assists clients with:
- Consultancy services - Recommendation and writing of regulatory strategies and solutions.
- Operational services - Compilation, writing, review and submission.
- Regulatory systems and processes - Support and advisory services.
Our clients are both headquarters and affiliates of pharma, generic and biotech companies, and we offer:
- Regulatory capacity - Flexible and competent regulatory resources.
- Insourcing and outsourcing.
KLIFO Regulatory Affairs Services covers the complete lifecycle of medicinal products, from recommendation of the path to market, to late-stage post-marketing activities.
- Our experienced regulatory affairs team provide consultancy, operational and writing services
- We provide scientific advice support (briefing package, LoQ, facilitate meetings with authorities)
- We prepare clinical trial applications and amendments (advice, compilation, writing, review, submission and follow-up)
- We make 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.
Our regulatory affairs specialists have worked in international environments, and with regulatory dossiers, procedures and interactions for Europe (with EMA and national agencies including all European procedures CP, DCP, MRP, NP), the U.S. (FDA) and a large number of other countries.
Vice President, Regulatory Affairs Services
T: +45 44 222 940