Submission Content Authoring
Our Regulatory Consultants demonstrate superior knowledge of product and process development. With a strong history of effective communication, our technical writers author key messages supported by scientifically-cohesive narratives, reports and data summaries.
Our Regulatory Consultants make critical content decisions and prepare investigational and marketing submission documents compliant with ICH and FDA/EMEA specific guidances, including:
- CTD Modules 2 and 3
- IND, CTA, IMPD
- NDA, BLAs, ANDA, 505(b)(2)
- Drug Master File (DMFs)
- Development Reports, Amendments, Annual Reports
Content Development and Mapping
DSI has developed a number of special proprietary submission risk assessment products and services to streamline your journey through the regulatory submission process, including:
CMC Development Plans — GANTT charts identify critical path activities and timelines to support CTD submissions
HealthChek™ — Gap Analysis and risk assessment of deficiencies in meeting Module 2 and 3 submission requirements.