Common questions about our model, how we work with companies, and what makes us different.

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From Pre-IND to NDA and everything in between, RRD has a proven track record of successful client engagements.

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RRD’s latest news stories, press releases, and other important announcements.

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Regulatory-Driven Strategy

Our approach is driven by regulatory benchmarks with a primary focus on reaching the proof-of-concept stage as efficiently and cost effectively as possible. We achieve this working with our clients to design an optimal development strategy consistent with corporate goals, building a robust operational plan, and then integrating with our clients to successfully execute the plan by combining our internal expertise with an extensive network of affiliate relationships. By framing development in terms of regulatory milestones, we are able to focus all resources on optimizing the asset. We achieve this by assembling an expert team and conducting evaluations in the following areas:

  • Scientific
  • Regulatory
  • Medical/Clinical
  • Toxicology
  • CMC

Following our analysis, RRD prepares a comprehensive diligence report including an analysis of key risks and possible actions to manage or mitigate those risks. From there, RRD works with clients to create a strategic and operational development plan designed to clear regulatory hurdles, accelerate product development to proof-of-concept, and place successful products on a path of increasing value.