QUALITY

COMPLIANCE

FLEXIBILITY

CONSULTING SERVICES FOR LIFE SCIENCE ORGANIZATIONS

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THE NEED


Unlike many other regulatory agencies (which often have the power to pull products from the market only after carrying out their own studies), the FDA acts as a gatekeeper for products in industries that it regulates. The burden of proof is on the product developer, which must show that its product is pure, safe, and effective in order to bring that product to market. FDA applies strict standards in order to ensure that any data supporting product licensure are reliable and reproducible.  FDA’s standards cover not only scientific practices, but also the methods used for documenting results, investigating failures, qualifying personnel, and many other operational functions.  In order to have its data pass muster with FDA, the product developer or testing laboratory must have in place Quality Systems that meet FDA’s standards.



CORE QUALITY PROGRAMS


In order to have a functional and compliant Quality System, an organization must establish certain key Quality programs.  These core programs include the following:




ADDITIONAL QUALITY PROGRAMS


Depending on the nature of the business, many organizations also require the following:




OUR APPROACH


We examine the client’s needs and then develop programs to fit the particular application.  Having developed similar programs for other organizations, we understand how to balance the need for compliance with the need for efficiency.  We can help you to avoid compliance pitfalls, as well as the efficiency pitfalls that materialize when Quality programs do not adequately address the need for flexibility and efficiency.



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