Services
RPI assists its clients in addressing regulatory issues related to the development
and registration of their products. RPI communicates effectively in oral and
written correspondence which results in successful Agency interactions and
streamlined drug development. Regulatory services can be provided for drug,
biologic and device products that are regulated by the FDA or other foreign
health authority. RPI offers a wide range of services including the following:
Regulatory Strategy
- Global Development Strategies
- Due diligence assessments for in-licensing opportunities
- Preparation of INDs, CTAs, NDAs and MAAs
- Preparation of Product Development Plans
- Acting head of Regulatory Affairs for start-up companies
Interactions with Global Health Authorities
- Client representation at meetings with Health Authorities
- Team preparation for meetings with Health Authorities
- Responses to FDA/foreign health authority requests for information
- Acting US Agent for foreign sponsors
Regulatory Operations
- Regulatory Publishing
- Submission Planning and Management
- Maintenance of clinical trial and marketing applications
Project Management Support
- Management of content and timelines for global clinical trial applications
- Oversight of contract vendors including CROs and contract manufacturers
Safety Reporting
- Review individual cases and assess impact on overall safety
- Prepare SAE narratives
- Develop safety monitoring plans
- Prepare safety sections of Annual Report, Investigator’s Brochure
Quality Assurance
- QA support of GMP manufacturing
- Conduct vendor audits
- Review clinical studies for GCP compliance
- Establish validation programs
Medical Writing
- Study reports, Investigator’s Brochures, pre-meeting briefing documents, integrated summaries of safety and efficacy, manuscripts, product labeling, SOPs
CMC
- CMC Amendments
- Stability Protocols
- DMF preparation and review
- Technology transfer
- Process development
