Pharmaceutical and Life Science FDA & Global Regulatory Consultants
V&C Valence Specializes in managing regulatory enforcement actions, which include:
- Prevention, Remediation, and Certification
- Compliance with Regulatory Requirements
- Attaining Compliance Sustainability
Strategic FDA Consulting & Tactical Expertise
V&C Valence team of regulatory experts applies a practical proven approach to solve compliance issues.
Site Compliance Program (SCP)
Reduce your FDA compliance exposure with V&C Valence proprietary program and expert guidance on responding to 483 observations. In addition, provide advice on how to handle regulatory inspections.
Quality System Remediation
A comprehensive approach to identifying regulatory and QMS gaps by implementing effective remediation plans and preventing a recurrence.
Investigation, Deviations, and CAPA Review & Remediation
V&C Valence provides guidance, and technical support to ensure complete investigations, effective CAPA program and remediation strategies.
Batch Record Review and or Certification
Expert and independent review (onsite or remote) of batch records for accuracy, data integrity, and CGMP compliance.
Onsite or Remote FDA Triggered Audits
V&C Valence inspection readiness program ensures clients are “inspection ready” at all times.
FDA Facility Registration
V&C Valence supports FDA Facility Registration and U.S. Agent Services for Worldwide Facilities. Experts will help you navigate the FDA Facility registration and renewal process efficiently.
The V&C Valence Approach to FDA & Global Regulatory Compliance
Strategic Planning Session
System Follow Up & Support