Regulatory Affairs

Regulatory Affairs

At EL PHARMA Representation Services of PHOENIX group, we are committed to delivering Regulatory Affairs services that adhere rigorously to both European and local legislation, guaranteeing compliance for all products under our management.

What our Regulatory Affairs Services Include

From essential support activities to full-fledged services depending on the partnership model and/or the countries in scope. 

Marketing Authorisation Holder Services from regulatory strategy and application to post-approval lifecycle management in non-EU PHOENIX markets.

Local representative on behalf of partner including:

  • Point of Contact with Authorities
  • Regulatory Intelligence
  • Product Information management
  • Management of the regulatory approvals for repackaging activities and supply of non- registered/foreign packs to the market
  • Management of the regulatory approvals for advertising and promotional materials, etc.

Full Regulatory affairs services from regulatory strategy to lifecycle management in non-EU PHOENIX markets.

Why choose us

Expertise and Innovation in Pharmaceutical Industry

Innovative pharmaceutical services across Europe, delivering comprehensive solutions from distribution to retail.

Team and expertise

Whether it is navigating complex regulatory requirements or providing guidance on compliance matters, our dedicated team is equipped to assist at every stage of the regulatory process. 

Partner with us

Make a Difference

With extensive track of records in successfully serving partners across pharmaceutical industry, we are committed to bridging the healthcare gap across Europe.