TCG offers a variety of services to FDA-regulated companies. We offer practical, tailored solutions that align global quality capabilities with business strategy. We will work with your team to create an atmosphere of strong compliance. 

  • GMP training 21CFR 211
  • Quality System Regulation Training
  • ​FDA 101: Understanding the Regulatory Process
  • Inspection readiness
  • Data integrity

Tanksley Consulting Group Pharmaceutical Quality Regulatory Compliance Consulting. Sarah Tanksley


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 regulations.

Consulting Services & Training
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+1 (757) 870-3739
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+1 (757)  870 - 3739
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  • FDA Submission / Application Review
  • Routine cGMP and best practices audits
  • Mock inspections
  • Inspection preparation and coaching
  • 483 response preparation and/or review
  • Warning letter response assistance
  • Remediation activities
  • Third-party due diligence audits
  • Data integrity audits, life-cycle mapping, and remediation
  • Deviation investigation and CAPA assistance
  • Out of specification and laboratory investigation assistance
  • Quality & Compliance Policies & Standard Operating Procedure Preparation & Optimization
  • Quality Assurance and Quality Control Training (FDA, GMP, Validation)
  • Quality System Development, Assessment and Optimization
  • Batch record review and optimization
  • Process mapping and streamlining
  • ​Compliance strategy planning
  • Technical support for law firms