Expert Medical Writing & Regulatory Publishing

Expert protocol design and comprehensive study documentation 
Transform your study concepts into scientifically sound, regulatory-compliant protocols and detailed study reports. Our medical writing experts collaborate with your clinical teams to develop comprehensive documentation from initial concept through final reporting. 

Key Services: 

• Initial protocol synopsis and full protocol development 

• Protocol review, optimization, and amendments 

• Statistical sections and sample size calculations 

• Complete CSR development meeting ICH E3 guidelines 

• Synopsis and executive summary creation 

• Statistical analysis integration 

Strategic documents that accelerate approval pathways 
Navigate complex regulatory landscapes with expertly crafted submission documents. From CTD Module 2 summaries to specialty submissions, our team understands what regulators need for efficient review and approval. 

Key Services: 

• CTD Module 2 clinical and non-clinical summaries 

• Integrated Summary of Safety (ISS) and Efficacy (ISE) 

• Briefing documents for regulatory meetings 

• Orphan drug designations and breakthrough therapy submissions 

• Fast track submissions and post-market commitment documents 

Comprehensive safety documentation for regulatory evaluation 
Transform safety data into clear, detailed narratives that demonstrate thorough safety evaluation. Our medical writers specialize in presenting complex safety profiles in formats that support regulatory decision-making. 

Key Services: 

• Individual case safety narratives 

• Development Safety Update Reports (DSURs) 

• Periodic Safety Update Reports (PSURs) 

• Risk management plan documentation 

• Investigator's Brochure development and updates 

• PK, efficacy, and safety data integration 

Clear, compliant documents that protect participants 
Develop participant-friendly documentation that meets regulatory requirements while ensuring true informed consent. Our writers balance scientific accuracy with readability, creating documents that participants understand and regulators approve. 

Key Services: 

• Informed Consent Form development and optimization 

• Readability assessment and improvement 

• Multi-regional regulatory compliance 

• Amendment development 

• Regulatory compliance across regions 

Scientific publications that advance medical knowledge 
Bridge the gap between clinical research and medical practice with high-quality publications. Our team helps you share research findings through peer-reviewed journals, conference presentations, and medical communications. 

Key Services: 

• Manuscript writing and development 

• Abstract creation for conferences 

• Poster presentation development 

• Scientific communication strategies 

Professional publishing services with rigorous quality assurance 
Ensure your documents meet the highest publishing standards with comprehensive quality control and regulatory publishing expertise. From formatting to electronic submissions, we handle technical aspects while maintaining scientific excellence. 

Key Services: 

• Document formatting and standardization 

• eCTD compilation and publishing 

• Electronic submission gateway dispatch 

• ANDA, NDA, and medical device submissions 

• Multi-tier scientific and editorial review 

• Compliance verification with style guides 

• Data verification and accuracy review