Preclinical
As your company begins establishing the purity, stability, and reproducibility of your biologic, you must gain approval through an IND application to advance along the regulatory pathway. The DataRevive team will tap their earned FDA and industry expertise to prepare your IND application, write the required dossier, conduct Pre-IND FDA meeting preparation, and represent you in these face-to-face sessions if needed. We are also versed in Fast Track, Orphan Drug Designation (ODD), and Breakthrough Therapy designations and will help you determine if your product development can be expedited via one of these pathways.
Our nuanced expertise is reflected in DataRevive’s stellar track record of safe-to-proceed determinations for submitted IND applications.
Clinical Trials
Once IND approval is secured and your biological product begins clinical testing in human subjects, DataRevive provides support through all phases of the clinical trial process. From clinical study execution to PK/PD modeling, clinical study results analysis, BLA preparation, dossier writing, BLA submission, and marketing application submission, DataRevive is built to help you achieve approval quickly and move smoothly into the manufacturing phase the moment you have it.
Marketing and Safety Monitoring
Because DataRevive’s in-house capabilities are geared towards both supporting all regulatory aspects of biologics development and the business of providing biologics to consumers on the open market, our team is a one-stop-shop for the full regulatory approval lifecycle. From GMP audits to pharmacovigilance, we help ensure your biological product remains safe and accessible to patients long-term.
