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.

Anne Tingsgård


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


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