Pharmacovigilance Medical Writing

Specialist Safety Medical Writing, Led by Industry Expertise

Acadustri Limited is led by the author of Pharmacovigilance Medical Writing: A Good Practice Guide, and brings exceptional expertise in safety medical writing. As a trusted partner to biotechnology and pharmaceutical companies, we provide leadership, expert content development, and strategic guidance on the structure and clarity of all types of safety reports.

We understand the regulatory expectations and scientific nuances across the product lifecycle—from early clinical development through to post-marketing surveillance. Whether you’re an emerging biotech or an established pharma team, we tailor our support to help you meet global safety reporting requirements with confidence.

We support the preparation of safety documentation across all phases:

During clinical development

  • Development Safety Update Reports (DSURs)
  • IND Annual Reports
  • Clinical SAE Narratives

In preparation for marketing authorization

  • Summary of Clinical Safety (CTD Module 2.7.4)
  • Integrated Summary of Safety
  • EU Risk Management Plans (RMPs), US REMS & associated education materials
  • Literature searches and reviews

Post-marketing phase

  • EU PSURs / PBRERs
  • US PADERS / PAERs
  • 120-Day Safety Update Reports
  • Clinical Overview Addenda (e.g., for Type II variations and SmPC changes)
  • Safety reviews and summaries, including ad hoc reports
  • Response to Questions documents
  • Benefit-Risk Assessment Reports
  • Safety Signal Assessment Reports
  • EU RMPs, US REMS & associated education materials
  • EU post-marketing commitments (e.g., PRAC PASS protocols, responses to RFIs and PASS Final Reports)
  • Literature searches and reviews

What our clients say

Working with Acadustri on our DSURs went exceptionally well. Their team demonstrated deep regulatory expertise, organizing complex safety data across multiple studies into cohesive, ICH-compliant documents. They met all strict deadlines and provided indepth, accurate analysis that ensured our submissions were seamless. Highly recommended for critical safety documentation!
Adrian Johnson, Senior Director, Global Drug Safety & Pharmacovigilance
Annexon Biosciences
Our collaboration with Acadustri has been built on trust, performance, and consistent delivery. Their team operates with exceptional discipline and precision, bringing scientific depth and regulatory rigor that materially strengthens the quality, clarity, and credibility of our aggregate submissions.
Ravi Patel, Senior Vice President, Global Patient Safety & Strategic Clinical Development
United Therapeutics

Let’s talk

Please contact us for a confidential discussion about your safety writing needs.
Call us on 07790 322 776

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