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Expert Medical Writing for Clinical Excellence

Crafting Precision in Every Document

Our specialized team ensures that each document is meticulously prepared to meet regulatory standards and support successful clinical outcomes.

Regulatory Submission Documents

  • Crafting comprehensive Investigational New Drug (IND) applications
  • Preparing detailed New Drug Applications (NDA)
  • Developing robust Marketing Authorization Applications (MAA)
  • Ensuring compliance with all regulatory guidelines and standards

Clinical Trial Protocols and Reports

  • Developing precise clinical trial protocols to guide study conduct
  • Compiling thorough clinical study reports that summarize findings
  • Creating endpoint justifications and statistical analysis plans
  • Maintaining consistency and clarity across all trial documentation

Safety Documentation

  • Generating detailed Periodic Safety Update Reports (PSUR)
  • Crafting expedited adverse event reports and safety narratives
  • Preparing Risk Management Plans to ensure patient safety
  • Ensuring accurate medical coding for safety database integration

Haleus Insights Hub

Dive into the latest research, insights, and innovations with our team of experts in the fields that matter most to clinical advancement.

Request For Proposal

We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Haleus CRO Expertise