Validation and documentation Besides the analytical examinations according to the regulations (EP, DAB, HAB), we offer specially developed techniques. New techniques are developed and validated in close consultation with our customers.

 Validation is performed in compliance with the ICH Q (R) guideline in close collaboration with the customer. You as the customer are kept constantly informed about the development of the method, the validation schedule, validation all the way through to the final report and you receive all necessary documents. If requested, model delimitation agreements govern the organisational, administrative services and tasks.

		Our services:
		Analyses according to existing monographs Preparation and validation of in-house monographs in accordance with ICH Q2 (R). Preparation of validation schedules and reports (in English on request) Preparation of standard work instructions Method transfer Conversion of all documents to the CTD format, adjustment to your method of implementation

 

Downloads:
Information leaflet	Auftragsanalytik, Outsourcing	German, PDF (274 kB)