James M. Clinton – founder of Quality & Regulatory Consulting, LLC

  • over 25 years industry experience with pharmaceutical and medical device companies. 
  • experienced microbiologist, QA manager and executive
  • developed validation protocols, pre-market submissions
  • extensive interactions with FDA inspectors and reviewers

Compliance and Remediation: FDA 483 / Warning Letter response, Strategic planning to sustainably correct inspection deficiencies

Regulatory Affairs: Medical Device 510(k) and PMA preparation, Drug CMC preparation, US Agent services for foreign device manufacturers doing business in US

Process Validation: Validation Master Planning, Facilities, Utilities, Equipment qualification, process validation, sterilization / aseptic process validation

Quality Systems: Quality Manual and Quality SOP’s – compliant with 21 CFR 210, 211, 21 CFR 820 and international standards (ISO 13485) custom prepared to meet your needs