A Cost Effective way for Sponsors to Maximize CMC Development and CMC Regulatory Compliance Capability
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.
An entire CMC group at your disposal
With MyCMCgroupSM you get access to API, DP, Analytical, RA and QA all in one package.
DSI’s team can help run your CMC Development, Regulatory, or Quality Compliance programs.
We get the job done
We are action-oriented. Your time is valuable so we roll up our sleeves and focus on delivering compliant, sustainable results.
An extension of your team
Our consultants will take ownership of the work fit right in, fill the gaps, and work collaboratively with you.
The right fit
MyCMCgroupSM ensures that you get the precise skill set you need at a cost that will maximize value on every project.
A deeper department
With our wide range of talented, experienced consultants, you are never left hanging if a project needs more help, an additional set of skills, or a complex question answered.
We make decisions and recommendations based upon logic and a thorough understanding of the regulatory process. This ensures that your results are clear and defensible.
We offer comprehensive solutions for adhering to today’s FDA regulations. Complying with FDA cGMP, GLP, and GCP regulations is a complex and daily concern for biotechnology and pharmaceutical companies, whether a virtual organization, operating company, or contract manufacturer.
DSI leverages our combined experience in all of these areas to help our clients increase compliance, accelerate time lines, and shorten their to-do lists.
Contact us for more information on how we can help with your Chemistry, Manufacturing and Controls (CMC) needs.