+1 (757) 870-3739
info@tanksleygroup.com
Tanksley Consulting Group Pharmaceutical Quality and Regulatory Compliance Consulting
Our experienced team of former FDA regulators and industry experts possess extensive experience supporting all phases of clinical and commercial production of biologics, small molecules, medical devices, and active pharmaceutical ingredients (API). We provide strategy and training to ensure the design of processes and operation of manufacturing facilities that fully comply with Federal Drug Administration’s current Good Manufacturing Practices (GMP) regulations. Our services include: routine cGMP and best practices audits, Mock inspections, 483 response preparation and/or review, warning letter response assistance, remediation activities, third-party due diligence audits, data integrity audits, life-cycle mapping, deviation investigation and CAPA assistance. Our training topics include: GMP training 21CFR 211, inspection readiness, data integrity.
Tanksley Consulting Group
Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley
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Our experienced team of former regulators and industry experts possess extensive experience
supporting all phases of clinical and commercial
production of biologics, small molecules, medical
devices, and active pharmaceutical ingredients.
- Pharmaceutical quality and regulatory compliance consulting
- FDA warning letters
- GMP expertise
- Data integrity audits
- For more about our services
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constructive • productive • instructive
+1 (757) 870 - 3739
A full service quality and compliance consulting firm, specializing in the pharmaceutical industry.
We provide modern quality system, regulatory compliance, regulatory affairs, and technical services to a diverse range of clients worldwide.