REGULATORY AND MEDICAL WRITING
LBRIA’s medical writing team delivers high-quality, regulatory-compliant documentation across the full product development lifecycle — from early regulatory strategy through approval and post-marketing requirements.
Our medical writers bring deep scientific expertise and a thorough understanding of FDA, ICH, and global regulatory expectations for pharmaceutical, biotechnology, and medical device programs.
We present clear and concise documentation to the regulatory authorities within the expected timeline.
Delivering Medical Writing at LBRIA
Our medical writers demonstrate exceptional attention to detail and a comprehensive understanding of scientific content, regulatory guidance, and specialized medical terminology. We translate complex scientific and clinical data into clear, consistent, and accurate regulatory documents that effectively support development, submission, and regulatory agency interactions. This disciplined approach is fundamental to producing documents that meet regulatory expectations and withstand scrutiny from health authorities and sponsors.
Collaboration is central to our delivery model.
LBRIA medical writers work closely with clinical operations, biostatistics, data management, and regulatory affairs teams, using flexible workflows that enable efficient communication and rapid response to evolving project needs. This integrated approach ensures alignment across functions and timelines.
All LBRIA medical writing deliverables are developed under rigorous quality control processes to ensure full compliance with study protocols, statistical analysis plans, and applicable regulatory guidance. Each document undergoes comprehensive quality control to verify accuracy, consistency, and completeness across text, tables, figures, and narratives, with full documentation maintained for sponsor review and audit readiness.
MEDICAL WRITING SERVICES
LBRIA provides medical writing support across all phases of development, including:
Regulatory Strategy and Early Development
Pre-IND documentation,
White papers and scientific position documents,
FDA meeting requests and regulatory briefing packages,
Orphan Drug and Rare Disease applications,
Fast Track, Breakthrough Therapy, and Accelerated Approval requests.
Regulatory Submissions
Investigational New Drug (IND) applications,
New Drug Applications (NDAs), Biologics License Applications (BLAs), and New Animal Drug Applications (NADAs),
Regulatory submissions in Common Technical Document (CTD) format, including:
Integrated Summary of Efficacy (ISE),
Integrated Summary of Safety (ISS).
Clinical Development and Reporting
Study protocols and protocol amendments,
Investigator’s Brochures (IBs),
Informed consent forms (ICFs),
ICH-compliant Clinical Study Reports (CSRs),
Patient narratives,
Protocols,
Standard Operating Procedures (SOPs).
Safety and Annual Reporting
Annual reports (INDs, NDAs, BLAs),
Development Safety Update Reports (DSURs) and related safety documentation.
