Our core competencies are:
- Application of chemical and physical analytical methods for the testing of medicinal products with an emphasis on the identification and quantification of the active ingredients in pharmaceutical preparations of known and unknown composition, and in comparable matrices (food and food supplements, cosmetics)
- Application of chemical and physical analytical methods for the testing of active ingredients according to the European Pharmacopoeia and other internationally recognized Pharmacopoeias
- Application of pharmaceutical-microbiological methods
- Development and validation of analytical methods
- Transfer of analytical methods
- In-depth knowledge of the requirements of the European Pharmacopoeia and other internationally recognized Pharmacopoeias regarding the analysis of pharmaceuticals and active ingredients and of the instrumentation used for this purpose
- Excellent expert knowledge and experience of the technical and the scientific staff
- Multitude of available analytical techniques, resulting from the requirements of the administrative instructions of the German Medical Products Act (AMGVwV), which states that OMCLs must be able to test and assess the control methods according to § 22 Section 1 No. 15 AMG and to test the samples according to § 5
- Set-up and maintenance of a quality management system according to ISO 17025, which is accredited nationally by DAkkS and internationally recognised by the MJA system of the European OMCL network