Strategic Regulatory Partner for Success in Netherlands

  • Tailored Regulatory Support
  • Product Maintenance & Compliance
  • Flexible Regulatory Teams

Greetings from
Freyr Netherlands

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:

Industries We Serve in Netherlands

Netherlands has a modern healthcare system in place that keeps the demand for Pharmaceuticals consistent. To be successfully marketed in the country, manufacturers and distributors must obtain an approval from Healthcare Inspectorate of Netherlands. As per the Directive 2001/83/EC, any new medicinal product shall be registered through a Marketing Authorization Application (MAA) following certain procedures:

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
  • Labeling 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

Looking for Regulatory Support in Netherlands

Contact us now for Expert Guidance and Support