Advanced Therapies Including Gene & Cell Therapies

Because of their inherent complexities, advanced therapies, such as gene and cell therapy, require a precise and intelligent regulatory and compliance, manufacturing, and quality assurance strategy as they move to market. DataRevive’s extensive background in advanced therapy regulatory consulting can afford your company’s autologous or allogeneic therapies the support required to move through the regulatory process and into manufacturing, marketing, and use quickly.

DataRevive provides consulting support across all phases of the regulatory pathway for advanced therapies.

Expedited Pathway Guidance

In scenarios where your advanced therapies fill an unmet medical need while treating serious or life-threatening conditions, the FDA supports the possibility of rapid approval through designations such as Fast Track, Orphan Drug Designation (ODD), Priority Review, Breakthrough Therapy, Accelerated Approval, and Regenerative Medicine Advanced Therapy. DataRevive stands ready to guide your advanced therapy through acquiring these designations wherever possible in the application, approval, and execution process.


Once a pathway is defined, DataRevive will provide active assistance in IND preparation and submission as well as designing for PK, PD, and toxicology studies that stand up to the expectations of regulatory authorities.

Clinical Trials

With IND approval secured and clinical studies designed, researchers can move through all phases of clinical trials to ensure the safety, proof of concept, and regulatory proof required to bring the therapy to market. DataRevive’s experts can help you execute clinical studies, meet manufacturing assessments, conduct clinical results analysis, prepare for face-to-face FDA meetings, write required dossiers, assemble and submit your BLA, and submit your marketing application.

Marketing and Safety Monitoring

Once approved to reach consumers, DataRevive offers post-approval support like audit response, pharmacovigilance, GMP and CMC strategy and response, marketing strategy, and more to ensure your therapy remains safe and effective for consumers in the marketplace.

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