Analytics

Pharmaceutical analysis and quality control of drugs

Authorities around the world place very high demands on the quality and safety of medicinal products. The measurements and methods used for drug testing are essential in identifying a drug and deciding on its release. To ensure these high standards, reliable equipment and methods of chemical analysis are required.

With our Good Manufacturing Practice (GMP)-certified partner laboratories, we provide fast and reliable support for projects from R&D to pharmaceutical quality control. Pharmaceuticals are processed using modern instrumental analytics, e.g. chromatography (UHPLC, HPLC, IC, HS-GC, and DC) and pharmacopoeia testing.

The determination of identity, content and purity as well as other pharmaceutical parameters is performed according to international and national pharmacopoeias such as Ph. Eur., USP, JP, BP, etc. Analytical testingof active pharmaceutical ingredients and finished products can also be performed according to customer-specific methods.

Some GMP-certified partner laboratories have a manufacturing authorization for batch release testing according to § 13 (1) German Medicines Act (AMG) and Qualified Persons (QP) with their own QP-certified batch release testing. Selected laboratories in our network also hold a permit in accordance with § 3 of the German Narcotics Act (BtMG) for drugs containing narcotics.

With an established partner for microbiological testing, we can also providefull servicefor your finished drug product testing.

We provide sound analytical-regulatory consulting, accompanying project management and analytical implementation from a single source. Feel free to contact us!