Biological Products

Because of the inherent complexity of biological products compared to small molecule drugs, bringing these innovations from discovery to market is oftentimes a more rigorous process that requires a nuanced understanding of regulatory requirements and CMC processes. DataRevive provides both, and our in-house, former-FDA roster of experts has the knowledge and experience to optimize your biologic’s path to consumers.

DataRevive provides consulting support across all phases of the regulatory pathway for biological products, including biosimilars.


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.

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