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
• 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 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 contactus@pharmabeistand.com Our medical writing team will review and provide feedback within 72 hours.