Chemistry, Manufacturing & Controls

Prioritizing Chemistry, Manufacturing, and Controls (CMC) early in product development can significantly reduce time and costs. Our experts in regulatory affairs and technical services at Premier Consulting provide essential guidance to ensure drug quality, safety, and consistency, setting you up for both near- and long-term success.

Using deep experience in formulation and design, site inspection and monitoring, protocol design and review, and method validation, we have led the successful submission of CMC dossiers for investigational new drugs, clinical trial applications, biologics license applications, and new drug applications. Additionally, our extensive network of contract manufacturing organizations allows us to identify the best service providers for your specific compound and dosage form, ensuring optimal performance within your time and budget parameters.