Trusted Experience
RPI is a referral based business that has successfully helped companies achieve their drug development goals for over 15 years.
 Customized Approach
With a thorough knowledge of the regulatory environment, RPI offers creative approaches to working effectively with FDA and other regulatory agencies.
 Optimize Resources
RPI can complement existing resources and reduce the need for investment in permanent hires.
 Maximize Value
The result is expedited drug development time and reduced overall cost.

Regulatory Affairs 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 are focused on 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
  • Advertising and promotional labeling
  • Gap analysis for Phase 3 start up

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

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, including 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