CMC Consulting

CMC Consulting

OUR CONSULTING STAFF HAS BEEN INSTRUMENTAL IN DEVELOPING AND MANUFACTURING DRUGS AROUND THE WORLD

Our scientific staff has more than a century of experience in the development and manufacturing of a wide range of drug products. Each of our scientists are uniquely qualified to identify solutions for a variety of our customer’s challenges and requests. We can participate on project teams and can lead CMC sub-teams while providing appropriate technical expertise to satisfy FDA and other worldwide regulatory requirements. Review our Scientific Advisory Board’s bios to learn more about their specific expertise, featuring Mike Radomsky, PhD and President of CMC Pharmaceuticals Inc., Cynthia Stevenson, PhD, and David Bennett, PhD.

Our extensive and collective experience provides CMC the ability to provide valuable input on a broad range of topics. These projects have included both very short term and multi-year projects.

Expert CMC Consulting services

  • CMC Project Plans: CMC has extensive experience in the creation of the chemistry, manufacturing, and control project plans to meet the strict FDA requirements for INDs, NDAs, and commercialization. We have a worldwide contract manufacturing organization network that can produce cGMP drug products for worldwide distribution for clinical studies and commercial use.
  • Investigational New Drug (IND): Our technical staff has participated in the preparation of CMC sections for dozens of IND applications. We are skilled in authoring and reviewing the CMC regulatory sections that are required to initiate a human clinical trial and are committed to initiating your phase I studies as quickly and efficiently as possible.
  • New Drug Application (NDA): We have participated in developing a large number of CMC sections for NDAs We understand the complexities of these regulatory documents and can participate on the cross functional teams to get your new drug approved as expeditiously as possible.
  • Supply Chain and Commercialization: Our team has worldwide experience in identifying the appropriate supply chain for clinical trials and worldwide production. We are connected with contract development and manufacturing organizations around the world to ensure continuous supply of your APIs and drug products for both clinical trials and commercial production.
  • CMC Troubleshooting: In our many decades of experience, we have participated in a wide variety of challenges in the formulation, analysis, and manufacturing of a wide range of pharmaceutical products. Our vast experience can help you identify not only the problem and cause, but determine the appropriate solution and corrective action to get your product back on track.

Take advantage of the extensive experience we have with CMC consulting. We also have a full-service CMC lab that can execute studies required for FDA-approval of new drug applications and investigational new drugs. Schedule a free consultation with us today!