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.