October 5, 2012
CTI Clinical Trial and Consulting Services (CTI) announces its expanded capabilities in electronic publishing and submission of regulatory documents in partnership with Octagon Research Solutions. Using Octagon’s Quantum Submission ManagerTM and Quantum Document PublisherTM, CTI can now prepare regulatory submissions in eCTD (electronic Common Technical Document) format, which is the worldwide standard for electronic submission of regulatory documents. CTI can develop, publish, and submit eCTD Investigational New Drug applications (INDs) and marketing applications in most regions of the world, including the United States, Canada, Europe, Latin America, Australia, and Asia. In some countries, eCTD submission is already mandatory, while in others, this process will be mandatory soon. In the US, the FDA currently accepts both paper and eCTD submissions, but has announced that eCTD submissions will become mandatory in 2014.
Utilization of the eCTD format simplifies life-cycle management for regulatory submissions from the IND to the Biologic License Application (BLA) or New Drug Application (NDA) in the US, and from the marketing application through all post-approval submissions in Europe. The eCTD structure serves as a backbone for CTI to build drug product dossiers from their foundation in an electronic format. It places every document in the required structure and facilitates efficient review by global regulatory authorities. An eCTD is comprehensive and includes all sections of the IND: clinical study protocols, amendments, and reports; annual reports, preclinical studies; correspondence with regulatory agencies; country-specific forms; chemistry, manufacturing, and control information; and all of the overviews and summaries required for marketing applications.
“CTI has provided regulatory services to our clients since the company’s inception fourteen years ago,” according to Lynn Fallon, President of CTI Consulting Services and Executive Vice President of CTI Clinical Trial and Consulting Services. “Our experienced medical and regulatory team members have expanded both in number and depth of experience within the US and globally. We continue to provide clinical development plans, briefing documents, protocols, as well as NDA and BLA submission documents for our clients. Our team works on approximately two dozen regulatory programs annually, providing our clients with the benefit of our extensive experience in order to ensure that submission documents are clear, concise, accurate and timely. CTI has experience with both paper and electronic regulatory submissions. We look forward to continuing to provide a complete suite of regulatory solutions to assist our clients navigate the regulatory process throughout the life-cycle of their products.”