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  • ENGLISH
  • FRANCAIS
  • Services
    • Services Overview
    • Clinical Trial Operations
      • Protocol Development and Study Design
      • Feasibility and Study Start Up
      • Patient Recruitment
      • Project Management
      • Clinical Operations
      • Centralized Monitoring
      • Decentralized Clinical Trials (DCT)
      • Centralized eTMF
      • Medical Services
    • Regulatory and Drug Development Consulting
      • Clinical Strategy
      • Nonclinical
      • Chemistry, Manufacturing, and Controls (CMC)
      • Regulatory Affairs
      • GxP Strategy Consulting
      • Publishing and Submissions
      • Medical Writing
    • Government and Public Health Services
    • Biometrics
      • Biostatistics and Statistical Programming
      • Data Management
    • Clinical Pharmacology Modeling Simulation
      • Clinical Pharmacology Integrated Drug Development
      • Model Informed Dose & Drug Development (MIDD)
      • Pharmacometrics (PMx), Pharmacokinetics, Pharmacodynamics (PK/PD)
      • DMPK and Translational Discovery and Development
  • Therapeutic Expertise
    • Therapeutic Expertise Overview
    • By Subject
      • Oncology and Hematology
      • Rare Diseases and Orphan Drugs
      • Infectious Disease and Vaccine
      • Cell and Gene Therapy
      • Central Nervous System
      • Autoimmune and Inflammation
      • Allergy and Asthma
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Medical Writing

  • Regulatory and Drug Development Consulting
  • Clinical Strategy
  • Nonclinical
  • Chemistry, Manufacturing, and Controls (CMC)
  • Regulatory Affairs
  • GxP Strategy Consulting
  • Publishing and Submissions
  • 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)

Contact Us

Let us partner with your team on bringing new therapies to light. Get in touch to get started.

CONTACT US

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    • Rare Diseases and Orphan Drugs
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    • Allergy and Asthma
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