PREMIER VALIDATION DOCUMENTATION SERVICES
Because Compliance is Everything
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About Us
Premier Validation Documentation Services is a Validation, GMP Compliance consulting firm dedicated to serve the FDA regulated Pharmaceutical, Biotechnology and Medical Device industries. We offer assistance in Validation Protocol Development, Standard Operating Procedure development, and Quality Guidance on validation requirements that will meet both the FDA's and your internal quality system.
The PVDS Mission
It is our priority to ensure that your organization complies with government regulations — domestically as well as abroad - to avoid missteps that could result in hefty fines, legal ramifications and reputation damage. Our mission is to provide you with sound guidance and technical documentation so your company can continue to focus your efforts on product or process development and not regulatory or compliance concerns.
What We Do
We provide high quality validation documentation and regulatory guidance to assist our customers in meeting all requirements dictated by both the FDA and the Code of Federal Regulations.
You can expect the following:
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Development of customized documentation for each customer
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A dedicated point of contact for each project
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24-Hour or less response time to all requests
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Professional and highly qualified staff for all projects
SERVICES
VALIDATION
QUALITY ASSURANCE
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Validation Quality System Review
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Assist with Protocol Deviations and Corrective Actions
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Training for Validation Staff in writing, execution, etc
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Standard Operating Procedure (SOP) Generation
CONSULTING
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Training on Steam Sterilization Validation Requirements
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Training on Depyrogenation Validation Requirements
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Guidance on the Life Cycle Approach to Equipment and Validation
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Validation Master Plan Review and Guidance
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21 CFR Part 11 Remediation and Gap Analysis Assessments
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Quality System Review to uncover Gaps in procedures and/or process
Why PVDS
PVDS has an exceptionally high rate of success for the following reasons.
Industry Knowledge
We are veteran professionals from Pharmaceutical, Biotech and Medical Device industries.
Response Time
When you partner with PVDS you are a top priority, with personalized and rapid responses.
Follow Through
We aren't satisfied until your company and its employees have the guidance and documents needed to meet regulatory compliance.