SUBMISSIONS

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.

PharmWrite™ — High functionality CTD templates, with emphasis on Guidance and Quality by Design (QbD) instruction.