Novotech made the call on the eve of the Generic Conference [Sydney 15 & 16 May 2007] where key stakeholders in Australia’s pharmaceutical sector will come together to discuss the role generic medicine will play in the market over the next 5-10 years.

www.terrapinn.com/2007/gmed_au/index.stm

Novotech has been involved in the registration of more than 70 new generic drugs and 150 new dose forms in Australia and New Zealand over the past ten years and, while over the past few years, Novotech has been increasingly involved in managing studies intended for European and US registration.

Awarded as “Asian CRO of the Year – Australia” for 2006, Novotech is arguably the most experienced clinical CRO in the bioavailability/bioequivalence space in Australia and New Zealand, and one of a very few with ISO 9001:2000 quality accreditation.

“Our model for service delivery involves end to end management of the process from protocol writing to regulatory agency submission and negotiation to approval,” said Safarian.

With its origins as a regulatory consultancy, Novotech is staffed by some of the most experienced regulatory affairs professionals in the Australian industry. “This is a real edge for our business,” said Safarian. “It enables us to rapidly assess the requirements for a new generic drug, including design and costing of study/studies for local and international registration.”

“In addition, our validated WinNonlin® platform provides best-in-class technology for modeling and analysis of pharmacokinetic parameters, including analysis and presentation of results for steady-state kinetics as required for modified release preparations.”

With access to clinic beds in Australia and New Zealand, together with laboratory analytical services in Australia, New Zealand and South Africa, Novotech is able to custom-design the BA/BE requirements of clients’ generic formulation for maximum efficiency in terms of cost, quality and timelines.

About Novotech
Headquartered in Sydney, Novotech is focused on the Australian and New Zealand markets but has worldwide reach through the company’s subsidiary in the United Kingdom and its USA operations on the East and West Coast.

As the largest independent CRO in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Novotech’s USA operations make it uniquely positioned to offer trials across the two countries, providing the benefits of Australia’s highly regarded cost-effective clinical trial capabilities, and at the same time take advantage of access to the much larger US market for rapid patient enrolment -a service that has to date only been available via large global CROs at higher overhead costs.

www.novotech-cro.com