Business solution
KLIFO Regulatory Affairs Solutions can assist you in navigating regulatory requirements related to drug development.
With our extensive experience of interacting with national and regional agencies, we can support all regulatory affairs-related needs throughout the development process – from defining a regulatory development strategy and offering scientific advice to supporting specific submissions.
Gitte Tange
Senior Director
Gitte Tange holds a Master of Pharmacy degree and a Diploma in Pharmaceutical Regulatory Affairs.
She joined KLIFO in May 2014 and has more than 20 years’ regulatory affairs experience, including 9 years in A-Consult.
Phone: +45 44 222 941
Email: gitte.tange@klifo.com
Expertise & therapy areas
Expertise:
KLIFO Regulatory Affairs Solutions have an expert end-to-end understanding of all your regulatory needs:
- Regulatory strategy – incl. GAP analysis, regulatory strategy and plan
- Regulatory project management and lead
- 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) incl. submission via EMA’s Clinical Trials Information System
- 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
- Medical devices:
- Regulatory support for medical device development (EU/MDR and FDA), including Notified Body interaction and pre-submission meetings
Our expert staff
Lene Thrane
Senior RA Specialist
Lene holds a Master of Pharmacy degree and joined KLIFO in July 2017.
She has more than 30 years of regulatory affairs and quality assurance experience within several areas in big pharma.
For the majority of these years, Lene has acted as global regulatory lead for various drug development projects in early and late clinical phase development.
Heidi Arp-Nielsen
Senior RA Specialist
Heidi holds a Master of Pharmacy degree and joined KLIFO in June 2015.
She has more than 10 years of experience working with global regulatory affairs in the pharma industry.
She has successfully developed and executed regulatory strategies for both development projects and mature products and has contributed to the approval of several MAAs and BLAs.