Batch Release and Testing
ADOH is the holder of a manufacturing and importation licence and can perform the import and EU batch release for your human or veterinary medicinal products. ADOH is licensed to perform:
- the EU batch release and import of sterile and non-sterile medicinal products
- the EU batch release and import of sterile and non-sterile investigational medicinal products (IMPs)
- the EU batch release and import of biological IMPs (cell therapy and “others”)
- the EU batch release and import of veterinary sterile and non-sterile medicinal products
ADOH has a network of subcontractors that can take care of the analytical and microbial testing of the samples. ADOH service also includes GMP auditing of API manufacturers and if necessary GMP support for your finished product manufacturing facilities. We have substantial experience in supporting non-EU companies in preparation to their first EU GMP inspections.
If requested ADOH can also support the distribution of your medicinal products into Europe.