WHAT WE OFFER

DS InPharmatics combines drug development with regulatory affairs expertise to ensure that your CMC program not only produces cGMP clinical trial materials but also delivers the data and information required to meet reviewer expectations for each stage of clinical development.

Full-Service Drug Development Teams
Our highly skilled professionals include Specialists in all areas of Chemistry, Manufacturing, and Controls (CMC) — we can guide your drug development programs to success from start to finish, or fill specific in-house know how gaps.

• CMC Drug Development Plans — GANTT charts of critical path activities, dependencies, and timelines

• Program Management — CMC product development

• CMC Consulting Services — Detailed descriptions of manufacturing and quality CMC services

• CMC HealthChek™ — Risk assessment and gap analysis of Module 2 and 3 CTD submission requirements

 
CMC Regulatory Affairs
Experienced CMC regulatory consultants assist you with filing and communication strategies with the FDA and EMEA.

• CMC Filing Strategy — Regulatory guidance interpretation and strategies

• Agency Liaison — Preparation for FDA meetings and development of briefing documents

• Submission Authoring — Full-service technical writing for domestic and foreign CTD submissions

• PharmWrite™ Templates — Guidance interpretation and Quality by Design content for CTD submissions

 
Due Diligence and Business Development Services

• Asset Transactions