Ensuring confidence in regulatory compliance
As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance. With our experience in drug, biologics, and medical device development, our regulatory professionals offer our clients comprehensive regulatory services to support clinical development, from the preclinical phase to the marketing application phase. Rho’s mission is to deliver quality clinical regulatory services in compliance with good clinical practices (GCPs) and applicable federal regulations.
Rho provides a professional, personalized approach to our regulatory consulting services, management, submissions, and clinical trial document review. Rho’s established standard operating procedures assure adherence to GCPs and federal regulatory guidance standards.
Experience in managing, writing, reviewing, and compiling regulatory dossiers, including:
- Pre-IND, end of Phase I/II and pre-NDA/BLA briefing packages
- Pre-investigational device exemption (IDE) briefing packages
- Scientific advice meetings with ex-US regulatory authorities
- Investigational new drug (IND) applications
- Investigational device exemption (IDE) applications
- Investigational medicinal product dossiers (IMPD-EU)
- Clinical trial authorization (CTA) applications
We are also experienced in writing and reviewing all regulatory and clinical documents to support clinical development including:
- Integrated product development plans, clinical development plans, and general investigational plans
- Protocol development (Phase 1 through Phase 4)
- Investigational brochures
- Informed consent and assent documents
- Clinical study reports (Phase 1 through Phase 4)
- Safety narratives
- Development Safety Update Reports
- Periodic Safety Update Reports
- Risk Management Plans
- Pediatric Investigation Plans
- Data and safety monitoring board (DSMB) charters and reports
- Interim data summaries
- Abstracts and manuscripts
In addition, Rho’s dedicated regulatory strategy and submissions team offers a wide spectrum of support for preparation and submission of marketing applications and comprehensive Regulatory Operations services for the strategic management, compilation, publishing, and submission of electronic dossiers.
Expert counsel for clients working with regulatory agencies
Our extensive experience managing communication with institutional review boards, the FDA, and other regulatory authorities enables clients to work more effectively in their clinical trials, while reducing time to market and conserving patent life. Whether we are providing expert advice, planning meetings, preparing pre-meeting briefing packages, or facilitating communication between the sponsor and the FDA or other regulatory authorities for pre-IND, End-of-phase 2, and pre-NDA/BLA meetings, our professionals guide sponsors through each step of the process.