Your Full-Service Biologic & Drug Regulatory Consultancy

DataRevive delivers deep real-world regulatory, CMC, preclinical, clinical, and GxP expertise to pharmaceutical and biotech innovators seeking product approvals in major global markets.

Our team includes a truly one-of-a-kind roster of former FDA CMC and clinical professionals, medical researchers, and industry operators who specialize in regulatory pathways across the global regulatory landscape.

No other consulting firm maintains the depth and breadth of expertise that DataRevive has in-house to support drug products through the entire regulatory approval lifecycle.

What’s more, DataRevive’s experts are not just consultants but hands-on partners in your success. We work alongside you to accelerate time-to-market while upholding high quality from the earliest stages on.

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Encompassing former FDA CMC professionals, CDER and CBER reviewers, seasoned clinical professionals, and industry operators, the depth of experience and knowledge within DataRevive’s team is truly unmatched in the market.

From regulatory strategy to CMC, preclinical, and clinical phase optimization, we have the right individuals to expertly guide you along the entire regulatory pathway—ensuring continuity to maintain high quality.

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As former regulators, we provide clients with an invaluable, nuanced understanding of health agency processes which is needed to craft optimal filings and responses. Our experts will lead you to the right regulatory pathway and then apply their highly specialized expertise to help you reach approval effectively and efficiently.

Additionally, through our strong regulatory intelligence-gathering efforts, we are able to stay on the pulse of changing requirements and proactively update filings when needed to ensure evolving regulatory standards don’t create approval delays for you.

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DataRevive’s world-class experts aren’t just consultants but hands-on partners in your success. We realize the vast health impacts your products can make and are committed to working alongside you to accelerate their time-to-market from the earliest stages on.

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DataRevive is a Validant Company

Together we bring you the leading regulatory, compliance, and quality experts in life sciences for end-to-end GxP consulting.

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