Our CMC Regulatory team offers both expert strategic advice and high-quality regulatory submissions, giving you access to the widest possible market for your product in the shortest possible time. We have developed strong relationships with the USA Food and Drug Administration and European Authorities, and regularly represent our customers at critical agency meetings.
Our experience encompasses international registrations of new chemical and biological entities, and pharmaceutical products containing established active ingredients (generics and 505(b)(2) applications). Our clients are based in the USA, Canada, South America, India, China, Europe and Australia, and include small to mid-sized specialty pharmaceutical companies as well as multi-nationals.
Our team has successfully registered new chemical entities and generic medicinal products for the US and European markets. In addition, our expert regulatory professionals prepare variations and amendments to existing licenses, and can assist you with environmental assessments, license renewals and annual reports. Whenever possible, we prepare our applications using the internationally-recognized Common Technical Document format. We can also file electronic clinical trial and market approval applications with the FDA, including SPL labeling, drug registration, establishment license renewals.
FDA Liaison and US Agent
Our regulatory personnel represent client companies in their interactions with the US Food and Drug Administration, and can act as your US Agent.