Validation Consultants

CiPharma supplies Validation Consultants on a project-by-project basis.Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our Validation Consultants can navigate their way through the regulations, helping you set up a compliant and practical validation approach.

Regulatory Changes

The regulator’s expectations of how validation is performed are continually changing, it’s no longer acceptable to have filing cabinets filled with validation documentation and at the same time have regular in-process and final product testing failures.

CiPharma’s ‘regulatory knowledge, practically applied’ approach to compliance means that we won’t over-engineer your validation efforts.

Product Development

Good business sense and regulations advocate that product development should be controlled and developed within a GMP / GLP quality framework. This quality framework and written records are crucial to facilitate validation later.

The general expectation is that products in clinical trials, should be controlled within a GLP environment, many aspects should be fully validated, i.e. sterility assurance, or computer systems validation holding medical records.