SERVICES
QUALITY/REGULATORY COMPLIANCE
Navigating regulatory requirements is essential for success in the highly regulated bio pharma industry.Our regulatory compliance services help you understand and comply with relevant regulations and FDA guidelines. From regulatory gap assessments to submission support, we provide expert guidance and support to ensure compliance and minimize risk.
- Compliance Regulatory Services
- Document Control
- FDA Regulations Assessment
- Quality Assurance/ Validation Master Plans Reports
- Standard Operation Procedures (SOP's)
- Audits
- Compliance and Quality Strategies
- Quality/Compliance Program
- CAPA
- Change Control
- Deviations
- 483 Response and Corrections
- Support and Certification for 483's Recalls, Warning-Letters and Consent Decrees
- Remediation Plans
CDBYGB