Regulatory Services

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

George Clinical are regional experts in unlocking the pharmaceutical and medical device regulatory landscape of the Asia-Pacific: Australia, China, India, Japan, South Korea, Hong Kong, Singapore, New Zealand, Sri Lanka, Taiwan, The Philippines, Thailand, Vietnam and Malaysia.

Regulatory Services

Our team are experienced regulatory and safety professionals with the regional knowledge (including local language and culture) and contacts needed to communicate effectively with the appropriate regulatory agencies.

Furthermore, with our offices in the European Union and the Unites States adding to our global reach, GC Regulatory Services can assist sponsors through the varied local regulatory and ethical requirements 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:

regulatory services
  • Preparation and submission of clinical trial applications 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.
  • Import/export permits for investigational product and biological samples.
  • Investigational product management, including distribution to and from depots and trial sites
  • Local labelling review
  • Regulatory Safety Reporting
  • Local Safety & Pharmacovigilance and/or Regulatory Responsible Persons

George Clinical Regulatory Network

 

The George Clinical Regulatory Network provides local regulatory and safety expertise and ongoing surveillance of the dynamic regulatory landscape throughout the Asia-Pacific region and beyond. The network allows GC to identify, analyse and react in real-time to regulatory change. Potential areas of risks and impact for our sponsors is rapidly communicated, with mitigation strategies to ensure local compliance of all clinical development and trial activity.

Global coverage, if required, is achieved through our network of regulatory service partners.

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.

The geographic reach of the GC Regulatory Network covers:

Australia, New Zealand, India, China, Taiwan, Malaysia, Hong Kong, South Korea, Singapore, The Philippines, Macau, Vietnam, Thailand, Indonesia, Sri Lanka, Czech Republic, Japan, United Kingdom and the United States.

Bespoke Regulatory Strategy and Clinical Trial Delivery

George Clinical has established partnerships with regulatory vendors to provide a bespoke, comprehensive regulatory strategy to help get your product to market. These vendors collaborate with GC Regulatory Services and Clinical Operations to ensure the regulatory strategy is translated into expedient clinical trial start up and delivery and that the data generated meets the requirements for regulatory filing and market authorisation.

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