Regulatory & Medical Writing

Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients' product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.

A well designed and implemented regulatory strategy is critical to getting a product to market quickly and in a cost effective manner. What sets Sainalytics apart from other CROs is that we only employ the most experienced personnel. The Sainalytics team has developed a deep understanding of the intricacies of the regulatory process that only comes with years of working within the FDA, and numerous pharmaceutical, device and biotech companies, and various contract research organizations and other vendors.

Our Regulatory Services:

  • Regulatory Strategy
  • Investigational New Drug Application (IND)
  • Investigational Device Exemption (IDE)
  • New Drug Application (NDA)
  • Biologic License Application (BLA)
  • Premarket Approval (PMA)
  • Sponsor / FDA Liaison / Representation, Document Preparation, Review & Submission
  • Regulatory Response Preparation
  • Representation of clients with regulatory authorities
  • Safety narratives

Medical Writing

From the early stages, Sainalytics medical writers are involved in critical aspects of your projects and we have clinical development expertise across all phases of drug development.

Our medical writers are here to assist you in the drug development lifecycle across Phase I to Phase IV. We have written clinical trial protocols, clinical study reports, briefing documents for regulatory meetings, and Investigator Brochures. Our documents follow ICH guidelines are written to be fully compliant with all regulatory requirements.

Document types:

  • NDA, PMA
  • IND, BLA
  • Protocol development
  • Clinical study reports (CSRs)
  • Briefing document for regulatory interactions
  • Regulatory submission documents
  • publishing
  • Medical Publications​