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Quality Digest

FDA Compliance

Pharmatech Establishes Regulatory Compliance Group

Published: Tuesday, January 23, 2007 - 23:00

Pharmatech Associates Inc. has established a Regulatory Compliance Group that’s designed to help the consultancy’s clients ensure long-term drug development compliance with Food and Drug Administration regulations.

The RCG’s team members include former FDA employees who have extensive knowledge of the agency’s requirements. The group specializes in guiding clients through the FDA’s new process analytical technology, which represents a shift away from the agency’s traditional product-centric inspection approach to a more process-centric approach that accounts for the myriad variables that affect product quality.

“Because Pharmatech recognizes the challenges facing the FDA and industry to coordinate and review compliance activities, we have developed a project management structure to leverage the strengths of each piece of the compliance puzzle,” says Calvin Wong, Pharmatech’s CEO.

Pharmatech is a consultancy that specializes in services to the life sciences market. For more information, visit www.pharmatechassociates.com.


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