REGULATORY COLLABORATION

We offer flexible medical writing and document publishing solutions to support many types of study needs, giving you the quality and timeliness that can keep your project on track. Drug development should be consistent with ICH and FDA guidelines to ensure safe, effectiveness, and high-quality products. We can plan a strategy, by collaborating with Biostatisticians, CDMs, Pharmacovigilance, Medical and Regulatory Affairs experts, in order to execute the perfect strategy to give you the best chance of regulatory approval.

 

  • Strategic direction recommendations

  • Briefing package preparation

  • Regulatory agency meeting statistical discussion and presentation

  • Regulatory submission-ready data, programming and analysis package

  • Integrated summaries of safety and efficacy

  • CSR statistical authorship

  • New drug/device application and other report (e.g., annual safety/IND reports) review and editing

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Get in touch with us today and let us know how we can help you