Tanksley Consulting Group, Affiliates

+1 (757) 870 - 3739

We have an extensive network of affiliates with a wide-range of technical expertise and regulatory affairs experience. We are ready to mobilize a team of experts to meet the specific needs of your project.

constructive • productive • instructive

PRESIDENT & CEO

Whether you want to develop your quality organization, improve operations, or ensure a critical initiative is successfully executed, we will ensure your company achieves its objectives.

+1 (757) 870-3739

info@tanksleygroup.com

TANKSLEY TEAM

Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley

Sarah Tanksley has over 15 years of laboratory and regulatory experience with both the NIH and FDA. She is an expert on a wide range of issues related to the FDA's regulatory requirements.

Experience

5 years as a Principal Consultant of Strategic Compliance with PAREXEL Consulting
4 years as a reviewer/inspector with the Office of Compliance, Center for Biologics Evaluation and Research, FDA.
7 years of research lab experience within the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the U.S. Military.
3 years as an adjunct professor in the Graduate Biochemistry and Molecular Biology Program at Georgetown University School of Medicine, teaching courses in cGMP Compliance and Regulatory Affairs.

Expertise

Warning letter and consent decree remediation
Data integrity remediation
Mock inspections
21 CFR 211
Deviation and laboratory investigations

Education

MS Regulatory Science, Johns Hopkins University
MS Biochemistry and Molecular Biology, Georgetown University School of Medicine
BS Biology, The College of William and Mary

Sarah B. Tanksley, MS

• Our multidisciplinary team of former regulatory inspectors and experienced quality assurance professionals understand the unique challenges of operating in a highly regulated environment.

• We offer practical, personalized solutions that align global quality capabilities with business strategy to create an optimized quality system and an atmosphere of strong compliance.