AZ Biopharm – Analytical Services under GLP, GCP and GMP

AZ Biopharm is an independent, medium-sized analytical service provider located in the northeast of Berlin. Our laboratories operate in compliance with GLP, GCP and GMP requirements and have been successfully inspected by the FDA as well as audited by European and German authorities. We are recognized for our regulatory reliability, high analytical quality, and long-term partnerships.

Our Services

Bioanalytics
AZ Biopharm provides comprehensive bioanalytical services with a focus on small molecules. We analyze pharmacokinetic (PK), bioavailability (BA), bioequivalence (BE), and toxicokinetic study samples under GLP and GCP. Samples from plasma, serum, whole blood, urine, and tissue are extracted and analyzed using fit-for-purpose or fully validated methods according to ICH M10.

Our managing and senior team has over 50 years of combined experience and maintains a portfolio of more than 400 validated assays, continuously expanding with new validated methods annually. Monoclonal antibodies (mABs) and ADA/nAB analyses are offered as complementary services, when required. All bioanalytical work complies with EMA, FDA, and ICH M10 guidelines, supported by membership in various bioanalysis and quality networks.

Pharmaceutical Laboratory Services / Quality Control

• Quality control of drug products, APIs, excipients, and starting materials

• Stability studies under regulated conditions

• Nitrosamine analytics and analysis of nitrosylated APIs, product-specific in-house validation

• Elemental analysis according to ICH Q3D, product-specific validated

• Cannabinoid analytics according to Ph. Eur.

• GMP analytics of medicinal cannabis, including assay, impurities, and residues

Regulatory & QP Services

• EU batch release of finished medicinal products

• Selected manufacturing-related activities, including Qualified Person (QP) release

We place particular emphasis on short and reliable turnaround times, typically 10–15 working days for GMP analytics, which can be further reduced via short-track processing. For highly complex API analytics, we collaborate within our holding structure with a specialized, FDA-inspected partner laboratory, and in microbiology we work with an experienced and certified partner in Berlin, covering the process from sample logistics to final reporting – all from one source.

With modern technical infrastructure, extensive regulatory expertise, and available laboratory expansion capacity, AZ Biopharm is well positioned to support customers flexibly and grow together with long-term partners.