Premier Consulting provides medical writing and editing services for a wide variety of regulatory documents, ranging from pre-IND submissions through post-marketing commitments. We have extensive experience supporting both single-document and large-scale submissions across a diverse assortment of indications. Our writers are familiar with regional healthcare authority requirements, ICH and GCP guidelines, and best industry practices, and our documents are prepared in eCTD format.
Premier Consulting’s regulatory medical writing 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
