The Contract Laboratory for Analytics
Diapharm Analytics GmbH is the contract laboratory of Diapharm. We design and implement analytical concepts for our clients - from the development and validation of methods up to stability testing.
The spectrum of testing provided covers medicinal products as well as products from neighbouring sectors such as food supplements, cosmetics or medical devices. The services provided by Diapharm Analytics GmbH comprise analytical advice, development of methods, validation of methods as well as stability testing (follow-up und on-going) and release testing. For our customers we analyse herbals and chemically defined medicinal products alike.
Upon request our contract laboratory processes analytical results relevant for marketing authorisation in compliance with regulatory requirements and with the contents of the respective marketing authorisation dossier. Besides that Diapharm Analytics supports national and international clients in pharmaceutical quality control. We are certified according to "Good Manufacturing Practice" standards (GMP certificate) and possess a manufacturing license for the release for marketing (manufacturing license). Qualified persons who are responsible for the release of medicinal products for marketing can therefore refer to our certified testations according to Annex 16 of the EU GMP Guideline.
The contract laboratory of Diapharm has emerged from the Zentralinstitut Arzneimittelforschung GmbH founded by the German Association of Pharmaceutical Manufacturers (Bundesverband der Arzneimittel-Hersteller, BAH). In 2006 we have taken over the analytical tasks of the laboratory of Dr. Kolkmann & Partner.
Situated in Oldenburg the Diapharm laboratory offers modern analytical techniques - such as High Performance Liquid Chromatography (HPLC) and release testing.
