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
Due Diligence and Business Development Services
My CMC GroupSM
At DSI, we understand the unique challenges associated with developing drugs, biologics, and combination products. DSI helps maximize limited resources by providing the right kind of support only as it is needed. Our experienced professionals can also step in during times of unexpected demand, managing one-time events as well as long term needs.
DSI helps companies maintain their competitive edge by helping to streamline the CMC, RA and QA process to achieve efficient drug development results and faster product registration.
MyCMCgroupSM ensures that you get the right consultant with the most relevant experience to address all of you CMC needs. Whether you are facing sterility concerns for an aseptically-processed biologic, developing a regulatory strategy for an FDA filing, or in need of a clinical trial packaging expert, we can help.