ELC has the experience and expertise to provide all regulatory support services required throughout the drug development process.

Clinical Trial Support

• Complete Clinical Trials Application (CTA) service (preparation and submission)
• Investigator Brochure (IB) and Investigational Medicinal Product Dossier (IMPD) preparation
• Investigational New Drug (IND) preparation
• IMPD and IND conversions
• Standalone review of Sponsor-prepared documents.

Drug Marketing/Product License Support

• Drug Marketing/Product License Support
• Nonclinical overviews
• Report tabulations
• Narrative summaries

General Consultancy Support

• Literature reviews
• Preparation of strategy or position papers
• Expert advice/problem solving
• Critical review of data (and/or independent, second opinion)
• Inward licensing reviews
• Preparation of Briefing Books
• Organization of and attendance at meetings with regulatory agencies
• Preparation of study reports/journal manuscripts.