Medical Writing

Working with Allucent’s skilled, multidisciplinary, medical writing team, you will benefit from the deep knowledge of our organization’s team of scientific experts. These experts are involved in an advisory role to ensure rigorous adherence to the highest quality standards. Our medical writers work in close collaboration with all disciplines including medical, clinical, and regulatory. The process begins with a thorough discussion with your team to explore and articulate your strategy and goals. From there, our tasks span the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting you with documents that meet all GCP and industry standards.

Our medical writing services include:

• ICH E3 compliant clinical study report (CSR)
• Investigator Brochure (IB)
• Investigational Medicinal Product Dossier (IMPD)
• Investigational New Drug (IND) file
• Manuscripts
• Clinical Development Plan
• Protocol (synopsis) development
• Study, country, and site-specific master informed consent forms (ICFs)
• New Drug Application (U.S. NDA)
• New Drug Submission (Health Canada NDS)
• Medical Device Application (U.S., EU, Health Canada)
• Marketing Authorization Application (EU, UK, APAC MAA)
• Premarket Approval (PMA)
• Pediatric development:
  • Pediatric Written Request for Exclusivity Pediatric Study Plan (U.S. PSP)
  • Pediatric Investigational Plan (EU PIP)