About
Services
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