NewswireToday - /newswire/ -
Wayne, PA, United States, 2010/02/10 - News Facts, Octagon Research Solutions, Inc. today announced that its Regulatory team successfully completed the eCTD (electronic Common Technical Document) pilot program for the Health Protection Branch (HPB) of Health Canada.
• As a result of successful completion of the pilot, sponsors may now utilize Octagon’s Regulatory services to generate New Drug Submissions (NDS) in eCTD format for submission to Health Canada without the need to submit a sample submission.
• Octagon’s Regulatory Services clients may reference Octagon’s sample submission in lieu of producing a pilot submission, thereby saving time in the overall submission process and in the transition to the eCTD submission format.
• Sponsors may still be required to conduct a pre-submission technical meeting with the agency as described in Health Canada guidance documents without the necessity for a sample submission.
• Patrick Thomas, associate director, Global Regulatory Affairs, Octagon Research Solutions, Inc. noted, “Successful completion of this pilot enables us to save our clients time and resources as they prepare to submit in eCTD format. The pilot experience also adds to our organizational understanding of the nuances of filing in the eCTD format.”
• Nancy Smerkanich, vice president, Global Regulatory Affairs, Octagon Research Solutions, Inc. added, “Health Canada has been moving quickly to support acceptance and review of regulatory submissions in eCTD format and have gained efficiencies in their review process. We expect the agency to continue to gain efficiencies as a result of electronic filings in eCTD format.”
• Health Canada
• Octagon’s Regulatory Affairs Consulting.
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon’s eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Harrow, UK. Octagon’s EDC Operations are located in Mountain View, CA.