Pharma and biotech

Pharmaceutical R&D and manufacturing

Distribute in Asia and Australia from Adelaide

More people live inside this circle than outside.

Adelaide has been rated as the most cost-competitive city for doing business in Asia-Pacific by KPMG on their Competitive Alternatives 2016 index.

South Australia’s labour costs are 9% below the Australian average.

Industrial land and office space are available at rates lower than other mainland Australian states. With a well-planned supply of industrial land linked to strategic infrastructure and transport corridors the cost of doing business in Adelaide is highly competitive.

With established domestic and international logistics for hi-tech goods, companies based in Adelaide can serve the national market and easily distribute throughout the rapidly growing Asia-Pacific markets.

Take advantage of Australia’s free trade agreements with Japan, Singapore, Malaysia, Korea, Thailand, Indonesia, and China.

Australian Advantage

Foreign investors are assured by Australia’s stable political environment as well as the efficiency and transparency of its legal system. Australia’s legislative and regulatory frameworks are similar to those of many developed countries in the Western world.

The World Heritage Foundation notes Australia “has recorded impressive economic progress without undergoing a single recession for almost 25 years”, describing Australia as benefitting from “lasting entrepreneurial development facilitated by an effective system of government, a well-functioning legal system, and an independent bureaucracy”. Australia is one of only five countries rated as economically free in the world.

Economic Freedom


2016 Index of Economic Freedom

Ethics approval in an average of 6 weeks

No IND application is required for First in Human clinical trials and Human Research Ethics Committee (HREC) approval requires an average of only six weeks and is valid in all participating jurisdictions.

This means trials in Adelaide save six to nine months compared to trials in the USA or Europe. Ethics submissions consist only of a protocol, investigator brochure and, when required, an independent toxicology report.

Trials in Adelaide are compliant with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP). This compliancy means your trials will be compliant with the US Food and Drug Administration, European Medicines Agency, and Japanese and Canadian regulatory bodies.

Local infrastructure and expertise

A one-stop-shop offering smooth transition from preclinical research to clinical trials, Adelaide features:

  • A world-class large animal research facility.
  • One of Australia’s largest and most experienced Phase 1 clinical trials units with a database of more than 13,000 active volunteers.
  • A range of established facilities for Phase 2 and Phase 3 trials.
  • Frequent ethics committee assessment via Australia’s first and largest group of private HRECs (multiple monthly meetings).

Adelaide has a full range of local providers for:

  • Study drug manufacturing.
  • Clinical, data and bioanalytical services for small and large molecule clinical trials.
  • Applied clinical pharmacogenomics (PGx) services.

43.5% cashback for clinical trials

Forty-three and a half per cent of R&D costs will be reimbursed in cash to eligible companies with an aggregated annual turnover of less than A$20 million (approx. US$15 million). A 38.5% tax offset is offered to all other eligible entities.

 

What’s covered?

Cashback covers all phases of development, from preclinical to phases one, two and three. Companies can claim the cost of R&D activities conducted overseas in support of their Australian R&D project, when certain conditions are met. The incentive covers costs including:

  • Clinical trials
  • Analytics
  • Study drug manufacture and related services

There is a solid track record of successful claims by companies headquartered overseas, such as the US, when conducting research in Adelaide.

What’s the process?

Before commencing R&D activities, investors interested in benefiting from the financial incentives must set up an Australian company with a local director. There is no requirement to hire full-time employees. A formal agreement with the parent company is required.

The whole process is inexpensive and can take as little as a month. Importantly, all intellectual property remains with the parent company. Consultants with a track record of successful claims are available in Adelaide.

Adelaide’s banking system is available to provide a loan secured against the cashback amount.

The R&D Tax Incentive is an Australian Government initiative jointly managed by AusIndustry and the Australian Taxation Office. For further information please visit www.business.gov.au and www.ato.gov.au.

Health Industries South Australia is the South Australian Government agency helping life sciences companies expand in Adelaide.