CMC Pharma Consulting

Our wealth of experience in the development and manufacturing of a wide range of drug products uniquely qualifies CMC Pharma to identify strategic solutions for the most demanding drug development programs. CMC Pharma provides phase-appropriate technical expertise to satisfy FDA and other worldwide regulatory requirements helping to ease the pathway to regulatory approval.

CMC Pharma provides valuable technical expertise on a broad range of drug product development disciplines. We offer CMC regulatory solutions and have specialized resources to support both short term and multi-year projects.

CMC Project Plans:

CMC Pharma 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. Our worldwide contract manufacturing organization network can produce cGMP drug products for global distribution for clinical studies and commercial use. We are experts in helping pharma companies, big and small, with their regulatory submissions.

Investigational New Drug (IND):

Having prepared CMC sections for dozens of IND applications, CMC Pharma is skilled in authoring and reviewing the CMC regulatory sections required to initiate human clinical trials. Our extensive experience supports initiating your phase I studies as quickly and efficiently as possible to advance clinical development in the pharmaceutical industry.

New Drug Application (NDA):

With our extensive experience in developing numerous CMC sections for NDAs, we thoroughly understand the complexities of these regulatory filings allowing us 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:

Our vast experience of drug development consulting helps companies overcome challenges in formulation, analysis and manufacturing can help you identify not only the problem and source but determine the appropriate solution and corrective action to get your product back on track. At CMC Pharma, we understand how important timelines are. As experts in regulatory consulting, regulatory submissions, and regulatory affairs, we help companies in the pharmaceutical industry turn innovative ideas into approved products.