Clinical Consulting Services
This NDA and BLA submission process is complex. Our team of top former regulators and clinical professionals apply their insider’s understanding of regulatory agencies’ nuanced processes and global requirements to help you ensure a timely, optimal approval outcome.
The DataRevive team will work directly with you to prepare for pre-BLA meetings, compile clinical trial study integrated safety and efficacy summaries, conduct GMP pre-approval mock inspections, and write and submit your final entire marketing application. Throughout the process, we help you refine your regulatory strategy in line with your selected pathway. Our clinical services include:
- Clinical Study Design, Synopsis Preparation & Protocol Writing
- Meeting Package Preparation
- GCP Inspection
- GMP Pre-Approval Inspections
- Pharmacovigilance
- SAE Report: 7-Day and 15-Day SUSAR
- Protocol Amendment
- PI Change/Addition/Search
- Annual Report
- ICF and IB Writing
- Orphan Drug Designations (ODDs)
- Pediatric Study Plans (PSPs)
DataRevive’s clinical team is comprised of former FDA CBER and CDER regulators, seasoned clinical research scientists, and medical professionals with decades-deep experience in the pharmaceutical and biotechnology industries. The hands-on guidance they provide is always geared towards helping you achieve approval quickly and move smoothly into the manufacturing phase the moment approval happens – so you can rapidly get your product to market and to patients in need.
