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Regulatory and Medical Writing Services

The collective experience of our organization comes through in every document

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.

Rho Regulatory and Medical Writers work collaboratively with Rho experts in regulatory operationsmedicalclinicalbiostatisticsclinical data management, and other departments to produce documents that reflect the regulatory, clinical, and scientific expertise and integrity of the entire organization.

Our experience helps us deliver a portfolio of regulatory and medical writing services to address the needs of every clinical research project including:

  • Integrated product development plans
  • Investigator brochures
  • Protocol development
  • Informed consents and assents
  • Investigational medicinal product dossiers
  • Clinical Trial Authorizations
  • Regulatory meeting briefing packages
  • Clinical study reports (Phase I, II, III, and IV)
  • Safety narratives
  • Development Safety Update Reports
  • Periodic Safety Update Reports
  • Risk Management Plans
  • Pediatric Investigation Plans
  • Data and safety monitoring board (DSMB) charters and reports
  • Interim data summaries
  • NDAs/BLAs/MAAs
  • Abstracts and manuscripts
  • Integrated summaries of safety (ISSs)
  • Integrated summaries of efficacy (ISEs)

 

Our document content reflects accuracy through meticulous quality control processes

Rho's internal quality control (QC), provided by our document preparation and review standard operating procedures, ensures regulatory compliance for the regulatory and medical writing team's documents.

Click here to learn more about Rho's Regulatory Submissions experience in addition to our Medical Writing Services.