Quality and CMC documentation

Temmler has comprehensive know-how in quality planning and the compilation of quality documentation (e.g. specifications, test specifications), as well as to establish and maintain of the product specification file and the IMPD quality module.

Testing of investigational products

Our fully equipped QC laboratories provide analytical services for the comlete supply chain covering starting materials like excipients and APIs, intermediate and final products. Tehe range of services includes method development, method transfer and method validation as well as release and stability testing in accordance with ICH guidelines.

Qualified Persons for

• the Release of the study medication according to Annex 13
• the Evaluation of quality systems for suppliers and, for example, third country manufacturers