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Corporate Partner Spotlight: Bestech GMP Contracting
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Bestech GMP Contracting provides comprehensive Quality Assurance and Technical Consulting Services in line with FDA’s current Good Manufacturing Practices (cGMP’s). Our end goal is assurance that the client manufacturing and support environment is compliant with the cGMP regulations (21 CFR Parts 210 & 211). Focus is on the FDA Quality Six-Systems Approach to Pharmaceutical cGMP’s: 1) Quality System 2) Production System 3) Packaging and Labeling 4) Materials System 5) Facilities and Equipment and 6) Laboratory Controls. We assess compliance across these elements and correct identified gaps based on risk management principals. Our close involvement enables transformation of quality and manufacturing practices into compliant and self-sustaining systems and processes.

We aid clients in responding to FDA 483 Observations and Warning Letters, then actively implement corrective action plans to bring the operation into compliance with the current Good Manufacturing Practices. Our solutions satisfy the regulations while being pragmatic to allow successful business continuity.

Our team of highly qualified, seasoned Engineers, Chemists, Pharmacists and Microbiologists have a long track record of cGMP compliance remediation success. Specific areas of expertise include: Quality Systems Design, Aseptic Practices, Facility and Equipment Design, Training, Validation/Qualification, Engineering Support Systems, GMP Documentation and Technical Writing.

Feel free to reach out to us to discuss how we can serve you or if you have any questions at all regarding Good Manufacturing Practices. You can call Matt Bestercy at 631-838-9083 or visit our website:

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