CompliancePath provides IT Regulatory Consulting services to Pharmaceutical, Biotech and Medical Device firms who are required to comply with: US 21 CFR Part 11 Electronic Record and Signatures, US & EU GMP Regulations, and the newly revised Eudralex Vol 4. Annex 11. We specialize in Risk Based Validation, utilizing industry guidance’s such as ISPE‟s GAMP 5 and PICS PI 011-3 Good Practices for Computerized Systems in Regulated “GXP”. U.S. Headquarters.
*IHIF and the Scottish Lifesciences Association provide reciprocal benefits to our member companies. Learn more about the partnership and our other international members here.