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EU MARKET RELEASE SERVICES

EUROPEAN MARKET SERVICE

KEY EU SERVICES

Manufacturers of drug products from outside the European Union and Mutual Recognition Agreement (MRA) countries are required to submit their product to batch re-testing for release in the EU. Current MRA countries include Australia, New Zealand, Switzerland, Israel, Japan, the United States, and Canada. All other countries are subject to the batch re-test release requirement with certification by a Qualified Person (QP).

The J. Molner team, with our EU GMP-certified laboratory and QP are capable of ensuring that your products are released into the market in a safe and timely manner. This service includes:

  • Batch testing and release for approved medical products according to GMP requirements

  • QP-certified batch release analysis

  • One-time and ongoing audits of manufacturing facilities to ensure compliance with GMP

  • Assuming the responsibility as a QP for your product

 

Take a look inside our GMP laboratory with our virtual tour here!

 

Review the comments to EU GMP Annex 16 from the Estonian State Agency of Medicines here.=

Contact us today to explore how we can help you get to market faster!

 

  • EU Market Release

  • Batch product quantitative and qualitative testing for active and related compounds

  • Packaging quality control

  • Review of shipping conditions and suitability

  • Documentation and QP support

Download
our Technical White Paper 
on
EU Market Release
Here

BOOK A 30 MIN CONSULTATION

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