ISI, a leading provider of software and services for the life sciences industry announced today that it has entered into a strategic partnership with Australian systems integrator, Pharma To Market Pty. Ltd., in anticipation of Australia’s adoption of the electronic Common Technical Document (eCTD) submission standard.
Under the agreement, Pharma To Market will act as ISI’s exclusive Australian reseller of ISI’s market-leading Regulatory Solutions Suite and provide full implementation, maintenance, and accredited training courses for ISI’s software products. Pharma To Market also offers outsourcing solutions for eCTD and paper publishing to companies in Australia and New Zealand. With extensive experience in global regulatory affairs, Pharma To Market is currently the only eCTD vendor in Australia to offer local support and an extensive range of eCTD solutions to companies in Australia.
As Australia gears up for eCTD adoption, pharma companies have moved a step closer to the opportunity for a smoother regulatory process and improved submission lifecycle management. Global players in particular will now be able to streamline and harmonise their regulatory process and filing submissions for multiple regions—North America, Europe, Japan, and Australia, among others—merely adapting applications for region-specific elements.
Pharma To Market’s director and principal consultant Nick Ward says: “This alliance is very well timed as Australia gears up both to implement eCTD and to benefit from all of the associated efficiencies. ISI is a global market leader in its field, with a range and depth of software capability that is second to none, so we are delighted to be able to draw on the company’s market-leading tools, techniques, and expertise.”
For ISI’s part, the partnership with Pharma To Market enables the firm to extend its offerings across the Australian market, bringing online a further market for its global clients.
“There is still a lot to do before eCTD is put into practice in Australia,” says ISI’s managing director for Europe Adam Sherlock. “The Australian regulatory authority [the Therapeutic Goods Administration] must focus on getting its review tool installed and ready to accept submissions, developing its business protocols, and ultimately beginning formal eCTD pilots. This gives Australian pharma organisations some time to play with as they get their own houses in order, so this is a great opportunity for them to strike up a conversation with Pharma To Market.”
For industry, the onus is on getting the business ready to adopt eCTD. This will require improving business processes. Large, global companies will need to ensure that their Australian affiliates are familiar with the tools and processes used at global headquarters and that staff are properly trained and ready to implement the formal electronic submissions. Meanwhile, locally based companies will need to decide on how they will implement eCTD—the tools, the processes, training, and so on—and adjust business practices accordingly.
“The opportunities for companies are immense, but the benefits will only be realised if companies are prepared in advance for the changes eCTD brings about. Furthermore, if they haven’t already done so, Australian companies should act swiftly to take advantage of the Australian government’s small-business and general-business tax break and invest in any hardware needed to produce compliant eCTDs. The tax break is available for eligible tangible assets until December 31, 2009,” Ward says.
Australia and the eCTD
To aid organisations in their attempts to become eCTD ready, Pharma To Market and ISI have joined forces to create a timely Webinar in which experts in the Australian regulatory market will discuss the ups and downs of eCTD implementation, the steps that lie ahead, and the key things pharma companies operating in Australia will need to know to prepare for eCTD.
• Thursday, December 10, 2009
• 4 pm eastern time (New York)
Webinar speakers include Pharma To Market’s Nick Ward, who has extensive insight into the Australian regulatory market, having recently been regulatory affairs consultant at Alphapharm. Nick is also thoroughly acquainted with European regulatory affairs, having spent a year with Generics (UK), helping that company prepare and submit applications via the Decentralised Procedure and the National Procedure. On his return to Alphapharm, he led a regulatory team responsible for the preparation and submission of applications in several key markets, including the European Union, the U.S., Australia, New Zealand, Canada, and Southeast Asia. This resulted in the successful registration of many products.
A further contributor is Peter Grant, regulatory affairs information systems manager and regulatory affairs manager for Australia, New Zealand, Asia, and Africa at iNova Pharmaceuticals, Australia (formerly 3M Pharmaceuticals Pty. Ltd.). With 37 years’ experience in the pharmaceutical industry, Peter has a proven record of successful product registrations. He was instrumental in helping restructure the 3M regulatory team and implemented many systems to enhance regulatory processes at the company. Previously, Peter was in regulatory affairs with Wyeth, Australia, and was also with Janssen-Cilag, Merck Sharp & Dohme, and Upjohn.
ISI is also proud to announce the premier issue of Sentinel magazine events.imagesolutions.com/SentinelMagazine, ISI’s communication forum for regulatory professionals. This first issue features articles by ISI subject-matter experts, pharmaceutical executives, and industry luminaries. Upcoming issues will follow suit. The magazine is an integral part of ISI’s Sentinel Program, which provides regulatory thought leadership through publications and Webinars. Visit events.imagesolutions.com/2009SentinelProgram to register for the Webinar.
About Pharma To Market
Pharma To Market Pty. Ltd. (pharmatomarket.com) is a regulatory affairs consulting company providing global regulatory support services for the pharmaceutical industry. Pharma To Market is proud to be the first company in Australia to offer services specialising in eCTD implementation and eCTD submission outsourcing.
Pharma To Market is a privately held company in Brisbane, Australia, with over 50 years of experience in the pharmaceutical industry.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.
Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.