Skip to content
Home
About Us
Services
Testimonials
Training
Contact
Clinical and Regulatory Documents
Clinical Study Protocols and Amendments
CTD Modules for NDA and MAA submissions
Response to Questions documents
Clinical Study Reports for Phase I to IV trials per ICH guidelines
Informed Consent Forms and Amendments
Summary Documents for IND Applications
Literature searches and reviews
Plain Language Summaries
Briefing Documents for EMA & FDA Scientific Advice
Clinical Evaluation Reports for Medical Devices
Paediatric Investigational Plans
Investigator’s Brochures
Pharmacovigilance Documents
PBRERs
120-day Safety Update Reports
Risk Management Plans
DSURs/IND Annual Reports
Benefit-Risk Assessment Reports
Quality Control
100% QC of all documents against source documentation and style guides
QC to verify consistency within a document or between documents in a filing application
QC to verify consistency against regulatory guidelines
Other Document Types
Ad Board meeting reports
Conference meeting reports
Slide decks for medical liaison training
Development of Standard Operating Procedure (SOPs) for medical writing documentation