Sarah Tanskley Consulting Group Logo Large

constructive • productive • instructive

+1 (757)  870 - 3739
Sarah Tanksley Consulting Group Plasmid

Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley

We help you navigate the complexity of the quality and regulatory system.

We work in tandem with your organization to help your people work more efficiently.

Tanksley Consulting Group Logo Sarah
Sarah Tanksley LinkIn

© 2016 Tanksley Consulting Group, Inc | All Rights Reserved


Quick Links

Regulatory Affairs

  • Medical Device Reporting for Manufacturers: This guidance document describes and explains the Food and Drug Administration’s (FDA, we, us) current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.

  • CDER Drug Safety Priorities: This report goes beyond previously issued safety-related reports to offer a broader picture of FDA’s safety efforts, highlighting the critical advantages gained through a range of multidisciplinary collaborations and partnerships. 

  • Data Integrity and Compliance With CGMP Guidance for Industry. DRAFT GUIDANCE. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) April 2016 Pharmaceutical Quality/Manufacturing Standards (CGMP)


+1 (757) 870-3739