Summit Medical Writing Group, Inc.

Summit Medical Writing Group, Inc. provides clinical and regulatory document preparation services to the pharmaceutical and biotechnology industries. Our services include medical writing, editing, QC review, and electronic submission expertise. Our mission is to partner your needs with our 20+ years of experience in the industry to provide high quality work in a timely manner.

Clinical Study Reports (Phase 1-4)
Integrated Summaries of Safety and Efficacy
Risk/Benefit and Other Clinical Summary Sections
120-Day Safety Updates
Patient Narratives
Annual Safety Reports
Toxicology
Safety Pharmacology
Pharmacology
Pharmacokinetics
Study Synopses
Protocols
Investigator Brochures

Content reviews

English language, grammar, punctuation reviews

Style and consistency reviews

Data verification and accuracy

Internal consistency

Adherence to templates and guidelines

Abbreviations, references, synopses

Bookmarks and hypertext links
Small to mid-sized clinical & regulatory documents
E-publishing and e-submissions 

 Regulatory consulting
 Drug development plans
 Protocol design
 Overall IND/NDA strategy

Style and format

Graphics, tables, figures

Consistencies with templates and guidelines
Development of customized templates & style          guides