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
SCHEDULE A FREE CONSULTATION

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.

Know-how + No guesswork = Saved time and money

Rapid Turnaround

Proven protocols are already in place, so V&C Valence expert consultants can respond with a course of action to correct FDA findings in 24 to 48 hours.

World-Class Experts

Regulatory Specialists with the highest education credentials, industry knowledge, and remediation experience to get  your project back on track.

Proven Process

Exclusive four-step approach to FDA compliance that begins and ends with top-tier execution, support, and management of regulatory enforcement action plans.

The V&C Valence Approach to FDA & Global Regulatory Compliance

  • Phone (icon)

    Consultation

  • Light bulb (icon)

    Strategic Planning Session

  • Chest (icon)

    Tactical Approach

  • Arm shake (icon)

    System Follow Up & Support

Industries We Serve

V&C Valence provides a tailored suite of compliance services to highly regulated industries for the pharmaceutical, life sciences, manufacturing, and medical device sectors.

Pharmaceutical Compliance | V&C Valence FDA Regulatory Consultants

Pharmaceutical

Life Science Compliance | V&C Valence FDA Regulatory Consultants

Life Sciences

FDA Manufacturing Compliance | V&C Valence FDA Regulatory Consultants

Manufacturing

FDA Regulatory Medical Devices | V&C Valence FDA Consultants

Medical Devices