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 which are critical requirement dfor the of any pharmaceutical company.

Our expert writers can work through flexible sourcing model and are well adapt to project requirement. Client can engage us by full or partial outsourcing for a specific document. No work is small for us, we pride ourselves with delivering accurate, cost effective and high quality documents with out most 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
  • PI PLLR
  • 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 World, including compilation and project management of electronic CTD (eCTD), non-electronic eCTD (NeeS) and Paper submissions
  • We also provide 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 medicalwriting@pharmabeistand.com Our medical writing team will review and provide feedback within 72 hours.

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