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Grampian Global Clinical Research Organisation
An Organisation backed by pharma experts from the Northeast of Scotland
Services we offer
Acting as a legal representative of China based pharmaceutical companies to submit applications for Clinical Trial Authorisation (CTA) to the UK/EU Authorities as stipulated by European Commission Directive 2001/20/EC
Acting as legal representatives of UK based pharmaceutical companies in China to manage submission of CTA applications to the State Food and Drug Administration (SFDA)
Facilitate compiling of all necessary documents required for CTA application
-Provision of scientific based backup consulting about the Investigational Medicinal Product (IMP) for first-in-human trials to ensure success of CTA applications
-Submission of parallel/sequence CTA applications to Research Ethics Committees (REC) in the UK for China based pharmaceutical companies and the vice versa for UK based pharmaceutical companies
Clinical trial management- logistical support, recruitment of top UK clinical investigators and subjects for Chinese Pharmaceutical companies seeking to enter the UK-Europe wide pharma market and the vice versa for UK based pharmaceutical companies seeking to enter the Chinese pharma market
Coordination of submission of periodic and expedited safety reports
Advising on setting up effective pharmacovigilance systems run by pharmaceutical companies to insulate against Marketing Authorisation withdraw
Facilitation of cost effective compiling of the Common Technical Document (CTD) and submission for Marketing Authorisation (MA) acquisition application in the UK for Chinese pharmaceutical companies and the vice versa for UK pharmaceutical companies in China
Specialist expert consulting at all stages of the product life cycle, from conception to MA acquisition
Regulatory affairs consulting
Provision pharmaceutical market intelligence
Training services-pharmaceutical english
Arranging drug development seminars/workshops for Nanjing based pharmaceutical companies
Expert specialist scientific staff recruitment
Facilitate research collaboration between Chinese pharmaceutical companies and Scottish University Research Centers
Contact
Contact SinoConnexion [here] to discuss how the Grampian Global Clinical Research Organisation can help you in your clinical trial needs.