The Pharmaceutical Quality System (PQS) extends from product development to technical transfer through manufacturing and product discontinuation.Our proven track record in regulations and best practice standards as they apply to Clinical Studies, Laboratory Management, Manufacturing, Distribution, Pharmacovigilance and Product promotion make us ideally positioned to support PQS development in one or all of the following phases:
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PQS Gap Analysis: We can perform a gap analysis of your operation and identify key areas for development or improvement.
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PQS Design: We can help you to design practical Quality System Elements tailored to meet the specific needs of your business
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PQS Development: We can work with you to develop Standard Operating Procedure and other Quality System Documentation to support your PQS
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PQS Implementation: We can work with your team to ensure the smooth introduction of change and provide on-going review to ensure the effective integration of new system elements into your operation
Testimonial-Wyeth
Country Manager
Wyeth Pharmaceuticals Ltd
2006
Technical Director
Biostor
2007
Pharmaceutical Quality System
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Good Distribution Practice (GDP)
Good Promotional Practice (GPP)
Good Pharmacovigilance Practice (GPvP)
Good Engineering Practice (GEP)