Premier Consulting provides technical and medical writing and editing services for regulatory submissions in eCTD format. Premier Consulting’s document preparation services include:
- Regulatory/health authority submission documents for the FDA and EMA
- Regulatory review – consistency of message, regulatory commitments
- Clinical documents – support for labeling
- Document quality control – data integrity
Regulatory Document Services
- Investigational new drug, new drug application, and market authorization application modules (2.4, 2.5, 2.6, 2.7)
- Investigator brochures
- Pre-IND meetings
- Development safety update reports
- Regulatory responses
- Pediatric plans
- Integrated summaries of safety and integrated summaries of effectiveness
- Briefing books
- Lay summaries for the European Union
- Health authority meeting materials
Clinical Document Services
- Protocols
- Protocol amendments
- Clinical study reports
- Annual reports
- Narratives
- Executive summaries