Overview

With the quality and accessibility of healthcare system, Netherlands stands a best bet for foreign manufacturers to invest in the region. The EU list of competent authorities oversees the Regulatory activities in the region. With the major reforms taken place in the Regulatory regime, getting enough ground on improved procedures for obtaining market authorizations in the region would be a great challenge for foreign manufacturers.

Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and proceed to mandatory Regulatory submissions for streamlined registrations and approvals. Freyr is capable to provide Regulatory services in Netherlands for:

  • Medical Devices
  • Pharmaceuticals
  • Biologics / Biosimilars
  • Nutraceuticals

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways, MAA & License Maintenance incl. variations
  • Dossier preparation, review and management
  • Regulatory procedures: National, MRP, DCP, CP, DMF, NDA, JNDA
  • Regulatory CMC
  • Regulatory Submissions
  • Pre-IND, pre-BLA, EOP2/3, PIP procedures
  • Labelling incl. CCDS, Target Product Profile and IMPD/Regional CMC Documents
  • CE Marking
  • Medical writing
  • MAH transfers

Freyr Advantages

  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines