Validation
Washington Division pioneered the concept of validation in 1986. We are one of the largest and most diverse compliance consultants in the biotech and pharmaceuticals industries, with more than 150 employees dedicated full-time to commissioning and qualification (C&Q) validation and Good Manufacturing Price (GMP) compliance.
Our combination of capabilities, resources, and expertise means our work will meet all international GMP and industry standards. We have proven relationships with regulatory bodies:
- Food and Drug Administration (FDA)
- European Medicines Agency (EMEA)
- Japanese Ministry of Health
We help to formulate policies and directions through our involvement with key opinion-forming bodies including:
- Parenteral Drug Association (PDA)
- International Society for Pharmaceutical Engineering (ISPE)
- Good Automated Manufacturing Practice (GAMP)
- International Standards Organization (ISO)
This expertise is crucial if a manufacturing process is deployed internationally.
Our senior consultants come from pharmaceutical and manufacturing backgrounds and work with regulatory authorities on a daily basis. We understand the challenges companies face and we offer global solutions.
Speed to market is a vitally important objective in our world of rapidly changing legislation and increasing competition. We work in partnership with our clients to ensure their facilities are validated economically in the shortest time possible and remain validated for future operations.
