Regulatory Documentation

Regulatory Documentation

Regulatory Documentation

Pharma beistand provides consulting services across the full drug development life-cycle. We collaborate with clients to provide high-quality regulatory documents that are critical requirements for any pharmaceutical company.

Our expert writers can work through a flexible sourcing model and are well adapted to project requirements. The client can engage us by full or partial outsourcing for a specific document. No work is small for us; we pride ourselves on delivering accurate, cost-effective, and high-quality documents with utmost ethical and specific standards.

Pharma Beistand can assist you in:

  • Marketing Authorisation Applications (MAAs)
  • New Drug Applications (NDAs)
  • Abbreviated New Drug Application (ANDA)
  • Supplemental NDAs and MAA variations
  • Core dossier preparation
  • Regulatory responses
  • Integrated safety and efficacy summaries (ISS/ISE)
  • Serious adverse event (SAE) narratives
  • Clinical Evaluation Reports (CERs)
  • The Common Technical Document (CTD)
    • Clinical summaries
    • Clinical overview
    • Non-clinical summaries
    • Non-clinical overview
  • Briefing documents
  • Annual report
  • Safety write up
  • PLLR
  • Patients information leaflet
  • Product information
  • Medical rationales
  • Medical data package
  • Biowaivers
  • PSUR
  • We can offer wide-ranging support and consultancy for all aspects of electronic submissions in Europe, the US, and the Rest of the World, including compilation and project management of electronic CTD (eCTD), non-electronic eCTD (NeeS), and paper submissions
  • We also provide a stand-alone document quality control service for all regulatory writing documents

You can ask any questions to our medical writing experts by sending your queries to Our medical writing team will review and provide feedback within 72 hours.

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