Supporting the Innovations of the Pharmaceutical & Biotechnology Industries

Whether you are developing small molecule or large molecule drugs, recombinant proteins, vaccines, or gene and cell therapies, our team of former FDA CMC and clinical professionals provides the knowledge you need to move them with speed and quality through global regulatory approval processes.

We have worked on the side of governance and approval, and know how to prepare INDs, BLAs, and NDAs for the greatest probability of acceptance without delays. From preclinical GLP study design to clinical strategy to pre-approval GMP inspections, we can expertly guide you along the entire regulatory pathway—ensuring continuity to maintain high quality.

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DataRevive upholds an exceptional track record for having IND applications accepted on first submission. In fact, in one year alone, we received 32 safe-to-proceed determinations from the FDA for INDs submitted on behalf of our clients.

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The NDA and BLA submission process requires nuanced understanding of regulatory requirements for late-stage drug development. DataRevive has the proven expertise to help you prepare for pre-BLA meetings, compile clinical trial study summaries, conduct GMP pre-approval mock inspections, and write and submit your final marketing application.

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To enable a smooth transition to compliant manufacturing following market approval, DataRevive also offers ongoing GxP support services. We help you ensure continuous delivery of your approved therapies to patients through GMP inspections, regulatory agent services, and CMC guidance through manufacturing changes.

As a Validant company, we are part of a team specializing in every facet of the GxP lifecycle and are ready to support the comprehensiveness of your regulatory, compliance, and quality needs.

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