Medical Device > Regulatory Compliance
- Regulatory strategies
- Compliance Audits, Assessments, and Gap Analyses
- FDA "mock" inspections for GMP, GLP, and GCP environments
- Warning Letter Remediation Services
- Preparation of responses to FDA 483, citations, and warning letters
- Audits for 21 CFR part 820 (QSR and QSIT Audits)
- Computer Systems Audits and Part 11 Assessments and Remediation
- FDA regulatory submission preparation/review
- Preparatory pre-approval inspection audits
- Preparation for FDA meetings and advisory meetings
- Vendor Audits
- Our Approach / Our People
- Project-based Services
- Experience / Program & Project Management
