The ability to manage and control changes is a key competence in the pharmaceutical industry to meeting business challenges and legal obligations and to ensure continued compliance with GMP and associated regulatory documentation.

Change management needs to be applied throughout the product life cycle and includes the oversight and management of the entire portfolio of changes. It is necessary to insure, for all changes, that the level of effort and formality of the evaluation should be commensurate with the level of associated risk, evaluation on scientific and business grounds including marketing authorization and contain provisions for confirming objectives were achieved.

Verta Life Science have the knowledge and extensive experience to assist clients in implementing a customized systematic approach to proposing, evaluating, approving, implementing and reviewing process changes in full accordance with regulatory requirements and ICH Q10 guidance.