Regulatory Submission

Pristyn Research Solutions

Regulatory Submission

A regulatory submission for a healthcare product includes any documentation or information submitted to a regulatory agency like CDSCO (India),USFDA (USA), MHRA(UK), TGA (Australia),MHLW (Japan), MCAZ (Zimbabwe), SWISSMEDIC (Switzerland), HEALTH CANADA(CANADA), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China),for review, for notification or in response to a request for additional information related to a healthcare products.

Regulatory submissions by Pristyn Research

Pristyn Research regulatory have experts employee proven software solutions to deliver compliant, timely submission component documents and valid electronic submissions. Pristyn Research helps you overcome the challenges that persistently arise duringregulatory submission, with innovative solutions and extensive experience, Pristyn Research submission publishing service specialists are available to partner with you to generate the optimum clarification for any clinical document submission and publishing need.

Pristyn Research completed several types of submissions, including Investigational New Drug Application (INDs) clinical trial authorizations (CTAs), investigational medicinal product dossiers (IMPDs), and end-of-Phase II (EOP2) submissions. Pristyn Research understands the environment under which strategies and practices evolve at the FDA and the European Medicines Agency (EMEA). Our massive experience and attention on quality has resulted in a 100 percent acceptance rate for submissions with the FDA.

From protocol development to clinical study reports and regulatory documents, Pristyn Research medical writers ensure clearly written communications for sites, investigators and regulatory agencies throughout the product development and commercialization process. Among the types of documents our medical writers prepare are

  • Clinical Documents
  • Clinical Protocol, Protocol Synopsis and Protocol Amendments
  • Investigator Brochures
  • Interim Clinical Study Reports (CSRs)
  • Final CSRs
  • Medical Monitoring and Patient Safety Documents
  • SAE Reports with Narratives
  • Annual Safety Reports
  • Regulatory Documents
  • INDs, NDAs
  • PMAs, IDEs, 510(k)s
  • Annual reports (IND, NDA, orphan drug, etc.)
  • Periodic safety update reports
  • Module 2 and Module 5 summaries
  • Non-clinical study reports
  • Agency Cover Letters and Communications
  • Briefing Documents
  • Agency Response Documents
  • Product Labeling
  • Requests for Meetings