A Track Record of Optimizing INDs
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.
Streamlining Time to BLA/NDA Submissions
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.
Lifecycle Strategies to Approval & Beyond
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.
