CHEMISTRY, MANUFACTURING AND CONTROL DOSSIERS FOR DRUG REGISTRATION
 
Whatever the scale or complexity of your project, Regulus has the contacts and the knowledge to maximize your chances of success with regulatory authorities across the world. Our CMC team offers expert advice and produces high-quality submissions, giving you access to the widest possible market 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).
 
International Registration

Frequent, direct interaction with the USA Food and Drug Administration puts us in a strong position when preparing and submitting investigational new drug applications and marketing applications for biotechnology and pharmaceutical products, including NCEs and generics. We also have extensive experience writing Drug Master Files for international product registrations and have worked with clients in the USA, South America, India, China, Europe and Australia. Our team has successfully registered new chemical entities and generic drugs in the US and European market for domestic and international clients.

Whenever possible, we prepare our applications using the Common Technical Document format. We can also file electronic ANDA applications with the FDA, including SPL labelling.

 
FDA Liaison and US Agent
Regulus frequently represents client companies in their interactions with the US Food and Drug Administration, and can act as the US Agent for companies that do not have a legal presence in the USA.
 
Technical Writing

Regulus’s regulatory scientists write expert reports, Quality Overall Summaries, clinical protocols and clinical study reports to meet ICH requirements. We have prepared the chemistry, manufacturing and control sections of new drug applications (including 505(b)(2) applications), generic applications, and have prepared drug master files. In addition, our expert regulatory professionals prepare variations and amendments to existing registrations, environmental assessments, licence renewals and annual reports.