Datafarm Successfully Submits First Electronic Submission for Vectura

October 23, 2008 - Press Dispensary - Datafarm, a provider of electronic document publishing services and regulatory submissions services for the life sciences industry, announces the collaboration with Vectura (Innovata-Biomed Limited) to gain unanimous acceptance in submitting Vectura’s first electronic submission.

Vectura and Datafarm submitted a Clinical Trial Application (CTA) submission electronically to the Medicines and Healthcare products Regulatory Agency (MHRA), which was completed by Datafarm’s highly experienced regulatory services team. The CTA was created using a variety of Datafarm software applications to incorporate Special Mail 5 considerations, to review the CTA for approval, and to ensure compliance with the International Conference on Harmonisation (ICH) requirements, before being submitted electronically to the MHRA. The CTA was successfully submitted on time and Vectura received acceptance of the submission from the MHRA.

Shy Kumar, CEO & president, said: “We are working with Vectura to help them achieve success in their submission process. Vectura is a company experiencing phenomenal growth and it is a partnership that we look forward to developing in the future.”

Janet Worrell, director of regulatory affairs, Vectura, said: “It was a great pleasure to receive the acknowledgement and acceptance of our CTA, and equally satisfying to receive it without any queries. Datafarm has demonstrated that the e-submission process can be effortless.”

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Notes for editors
About Datafarm Inc
Established in 1997, Datafarm is a provider of electronic document publishing services and regulatory submissions services for the life sciences industry. Datafarm augments the drug development process by providing custom and off-the-shelf applications worldwide, producing high-quality, and agency-compliant e-submission-ready documents. Headquartered in Marlborough, Massachusetts, USA, Datafarm has regional offices in California, the UK, France and India. To date, the company’s products have been used in compiling thousands of e-submissions. Its regulatory services group has joined forces with sponsors to submit hundreds of eCTD dossiers to the FDA, Health Canada, EMEA, and Japanese regulatory authorities.


About Vectura
Vectura Group plc is a product development company focused on the development of a range of inhaled therapies principally for the treatment of respiratory diseases. Vectura develops products to treat respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis.

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