Regulatory Affairs Services
 

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 team offers expert advice and produces high-quality paper and electronic submissions. We have developed strong relationships with the US Food and Drug Administration and European Authorities, and regularly represent our customers at critical agency meetings.

 
Clinical Trial Applications and Product Registrations

Our experience encompasses US FDA and international clinical trial applications, and registrations of new chemical and biological entities, as well as those products containing established pharmaceutical ingredients (generics and 505(b)(2) products). We develop high-level regulatory strategies to expedite products through clinical trials and into the market, and regularly represent our clients in meetings with the US FDA and international regulatory authorities. Regulus can act as the US agent for overseas companies.

Using mutual recognition or centralized procedures, we can manage the entire European registration process for new medicinal products as well as for generic products.  We have extensive experience writing Drug Master Files for international product registrations.

Regulatory Operations

Regulus Operations supports the production of submissions in both paper (“old” and CTD formats) and electronic formats. Whether you are submitting an original IND, NDA or ANDA, or an amendment, supplement, or variation to an existing application, or converting an existing application to eCTD format, we can publish and deliver an FDA/ICH-compliant submission to meet your needs.

In the ever changing world of regulatory submissions, Regulus RO works with industry leaders to stay at the forefront of eCTD requirements. By using our own highly qualified and experienced  staff to perform most of the e-publishing, and limiting the use of third party e-submission vendors to highly specialized activities,  we can offer affordable e-submissions to our client companies, regardless of the size of their company. Our publishing team works closely with the authors to ensure documents are written using industry templates with the appropriate granularity, and to ensure formatting consistency across the dossier. Throughout all stages of submission preparation, consideration is given to the potential lifecycle management of the application to ensure that accommodations to future changes and amendments can be made with little or no disruption to the overall message of the application.

Medical/Scientific Writing
Regulus writes expert reports, summaries, investigator brochures, protocols and clinical study reports to meet regulatory authority requirements.  Our team of experienced regulatory scientists prepare nonclinical, clinical and CMC sections of new drug applications.