FDA Compliance Management & Regulatory Support

Connecting Your Business To The Project, Project Cut-Out & Resources That You Need

COSERVE Provides FDA Compliance Management & Regulatory Support.

There’s nothing simple about overcoming the challenges of regulatory compliance in today’s environment. With the FDA, you have multiple regulatory provisions to satisfy.  We can help you overcome these obstacles.

Our Technology Risk and Compliance practice offers highly skilled and experienced Senior Consultants who can help you become compliant with the FDA. We are very experienced in FDA Compliance in the Product, Manufacturing and Information Technology sectors.

We can provide assessments, audits, computer systems validation, remediation and training in this highly complex environment of FDA compliance.  Let our consultant’s help you get compliant with the FDA.

Compliance management and supporting regulatory processes take a specialty resourcing engine to supply key individuals that have both a wide breadth of experience and areas of specialization that satisfy today’s stringent regulatory guidelines.

COSERVE has just that engine, with industry contacts, resourcing methodologies and trained domestic dedicated client teams that outperform our competition.

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Audits
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FDA Electronic Records
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Assessments
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Electronic Signatures Regulation
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Computer System Validation
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Quality System Development
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21 CFR 11
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Remediation
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Quality Management and Compliance Support
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IQ/OQ/PQ/SOP
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Ensure a Robust CAPA Process
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Validation
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Standardize Templates Created, Reviewed & Approved
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Compliance Training
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