EU Batch Release SERVICES

European Market 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!

 

KEY ServiceS

  • 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