HELPING YOU FIND YOUR WAY TO QUALITY AND REGULATORY SUCCESS
WHAT WE OFFER
Experienced in Quality, Regulatory & Clinical Compliance for Medical Device, Pharmaceutical, Biologics, In Vitro Diagnostics, ISO 9001:2015, Automotive & Aerospace
QUALITY SYSTEM ASSESSMENT & AUDITING
Finding Gaps & Opportunities
QMS DEVELOPMENT & IMPROVEMENT
Value Beyond Compliance
EDUCATION & TRAINING
Know, Don't Guess
REGULATORY INTERACTION SUPPORT
Preparation, Response, and Remediation
PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE
Satisfying EU PRRC Requirements
CLINICAL/PERFORMANCE EVALUATION REPORTS
CER / PER Authoring & Review