Clinical and Regulatory Writing

Common Technical Documents

Clinical & Non-clinical Overviews

INDS & IND Amendments

Investigator Brochures

Clinical Protocols & Amendments

Clinical Study Reports

Safety Narratives

Development Safety Update Reports (DSURs)

IND and NDA Annual Reports

Regulatory Agency Briefing Documents

Advisory Committee Briefing Packages

Scientific Communications

Manuscripts

Abstracts

Conference Slides

Conference Coverage

Posters

CME Slides

Standard Response Letters and FAQs

Customized Response Letters

Patient Information Leaflets

Clinical Research Services

Protocol Development

Product Development Strategy

Medical Monitoring

Data Safety Monitoring Board