Strategic FDA Consulting Services
V&C Valence team of regulatory experts applies a practical and proven approach to solve compliance issues
Site Compliance Program (SCP)
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Quality System Remediation
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Investigation, Deviation, and CAPA Review & Remediation
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Batch Record Review and or Certification
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Onsite or Remote FDA Triggered Audits
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FDA Facility Registration
Site Compliance Program (SCP)
Reduce the FDA Compliance exposure with the SCP implementation. Discover and reduce potential 483 observations. If the agency shows up at the factory, VC advises personnel on how to address the FDA Questions. Help with guidance and navigation on the live response. Review documentation and provide coaching. Reduce your FDA compliance exposure with our proprietary program and expert guidance on how to respond to questions during a live 483 observation.
Quality System Remediation
V&C Valence offers a comprehensive approach to uncover regulatory and PQS gaps, shortcomings, overkill, and redundancies, establish a remediation plan and prevent recurrence with confidence. Our top-ranked team of experts can guide your organization through the complexities of regulatory compliance, resolution of product problems, and FDA remediation.
Investigation, Deviations and CAPA Review & Remediation
V&C Valence provides Guidance, Oversight, Review, Training and Technical Writing Support for the Investigation, Deviations and CAPA. Provide guidance, oversight, review, training, and technical writing support for deviation investigations and CAPA systems and remediation strategies.
Batch Record Review and or Certification
V&C Valence will perform independent batch record reviews onsite or remotely. Factory receive an import alert which is published. Customs reviews if the company is on the list and if they are, the batch needs to be certified. Expert, independent review (onsite or remote) of batch records for accuracy and completeness of production history and process controls and certify that they adhere to FDA-approved procedures.
Onsite or Remote FDA Triggered Audits
Prepare clients for an FDA Audit, Site System Inspection, and For Cause Audits. Communication with the agency or FDA has a 2-year mandate so the company does a mock audit before getting the FDA inspection. Eliminate surprises and Improve FDA inspection outcomes. V&C Valence mock FDA audits prepare clients for GMP and For Cause audits and Site System Inspections.
FDA Facility registration
V&C Valence supports FDA Facility Registration and U.S. Agent Services for Facilities Worldwide. The step-by-step expert guidance you need to navigate quickly and efficiently through a complex FDA Facility registration and renewal process.