George Clinical are regional experts in unlocking the regulatory landscape of the Asia-Pacific: Australia, China, India, Japan, Korea, Hong Kong, New Zealand, Taiwan, The Philippines and Malaysia.
George Clinical has a team of experts who specialise in the regulatory requirements of the Asia-Pacific. George Clinical also accesses a global network of regulatory partners, providing us with complete global coverage. The George Clinical Regulatory Team assists sponsors through the various regulatory and institutional review boards and ethics committee processes to ensure the most efficient start-up of a clinical trial. Our service provision is flexible and can be structured to best fit your needs. Such services include:
- Preparation and submission of the initial clinical trial application to regulatory authorities and facilitating ongoing regulatory requirements.
- Supporting investigators with the preparation and submission of Institutional Review Board or Ethics Committee documentation and facilitating completion of ongoing Institutional Review Board or Ethics Committee requirements.
George Clinical provides advice and support for the import and supply and management of clinical trial investigational products.
- Import/export permits for investigational product and biological samples
- Investigational product (IP) management, including distribution to and from depots and trial sites Local labelling requirements
- Validation of labels
- Facilitation and management of third party vendors
- IP return and destruction procedures
Regulatory Affairs for Clinical Trials
George Clinical provide local and regional expertise to ensure ongoing surveillance of the dynamic regulatory landscape throughout the Asia-Pacific and India, from China and Korea in the north, to New Zealand and Australia in the south.
The George Clinical Regulatory Team includes experienced regulatory professionals with the regional knowledge and contacts needed to communicate effectively with the appropriate regulatory agencies. This allows us to anticipate and resolve any potential issues or challenges for your project. George Clinical will also review and analyse the potential impact of any regulatory changes and provide advice on applicability and integration, if required, into your development plan.
George Clinical can therefore provide meaningful advice and strategies tailored to your individual needs, based on the most current regional guidelines, as part of the global regulatory context.
In Japan, USA and EU we will liaise with our partners to ensure your regulatory requirements are met.
George Clinical helps unlock the regulatory environment of the Asia-Pacific