Validation & Compliance
CDI-Life Sciences assists clients with GMP reviews of new facility design, evaluation of existing
operations, cGMP audits of facilities/suppliers and FDA regulatory consulting. We develop validation
master plans, plan and schedule validation projects and prepare and execute IQ, OQ and PQ protocols.
In addition, we provide GMP training and certification and pre-FDA plant inspections. We have
developed and proven a methodology for efficient integration of commissioning and validation activities
in accordance with ISPE guidelines.
Commissioning & Qualification
We develop, plan and execute protocols for commissioning for GMP and non-GMP pharmaceutical
industry facilities. We have current experience with implementation of ISPE Commissioning Baseline
guide recommendations.
To find out more, contact us.