Eurofins BioPharma Product Testing Budapest Kft.

Eurofins BioPharma Product Testing Budapest operates as a GMP-certified laboratory with extensive experience in chemical testing and EU batch release. We support the analysis of raw materials, excipients, intermediates, drug substances and finished sterile & non-sterile pharmaceutical products for small molecule drugs for the Human and animal health industries.

Imported human finished products can be retested and then released to the EU market by our Qualified Persons. Oral dosage forms and sterile products are tested and released regularly by our company.

With the help of our subcontracted partners, the whole supply chain (importation, custom clearance, warehousing, batch testing and release, distribution) of imported products can be offered to third country manufacturer or Marketing Authorisation Holder.

Analytical Development can be carried out for small molecules and then analytical methods are validated according to ICH and Customer requirements.

Stability studies, including storage according to ICH guidelines of samples, can be carried out at our site.

Residue analysis (elemental impurity, residual solvent, nitrosamines) of drug products and raw materials can be carried out with analytical methods developed and validated at our site.

Our teams of scientists and project managers partner with you throughout the outsourcing process from testing to monthly reports to 24-hour online data access at LabAccess.com.

In close cooperation with our Eurofins BioPharma Product Testing network of laboratories across Europe, we are able to offer the full service package, including microbiological and potency assay testing.

Our local presence ensures personalised customer support for all analytical needs.