DEVINE MEDICAL CONSULTING

We provide quality consulting to the Medical Device, Biotechnology and Pharmaceutical companies. In depth knowledge and applicability of various regulations pertaining to medical devices and drugs. Expertise in ICH, PIC/S guidelines, EudraLex, ANVISA, JPAL, TGA, MDSAP, ISO 13485, 21CFR part 11, GLP, cGMP, and 21CFR part 820... Many companies struggle to perform Quality and Regulatory gap analysis to demonstrate compliance with global cGMP and GMP requirements. Are you looking for a consulting company that is committed to help improve your quality management system and regulatory compliance processes that is a step above the status quo? If so, give us a call or send an email to discuss!... We help to develop and lead Inspection Readiness Initiatives including inspections, readiness planning for Sponsors, Sites and Vendors; Gap Assessments and Remediation activities; Inspection Readiness Training including Coaching and Mock Inspections.

Also known as: Devine Medical QARA Consulting LLC

Primary location: Providence United States