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2010/8/13
Clinical Trials in Russia. 2nd Quarter 2010  2010/5/17
Clinical Trials in Russia. 1st Quarter 2010 2010/2/24
Clinical Trials in Russia. Year 2009 2009/12/15
SynRG becomes the first Russian member of EF GCP 2009/11/28
GCP Training in Kazakhstan
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Regulatory support is essential to the drug development process, and SynRG is devoted to serving as a regulatory partner for the success of a clinical development program. Our specialists can offer support in study start-up activities as well as in ensuring regulatory compliance.
Our careful attention to detail and excellent relationship with the regulatory authorities help to expedite the regulatory review process and to shorten drug development timelines. SynRG advisory regulatory service can provide you with help in establishing a strategy for registration in Russian Federation and other CIS countries.
SynRG Regulatory Affairs Service include:
- Regulatory submissions in compliance with local requirements;
- Confirm presence of all necessary documents;
- Review protocol requirements;
- Consultancy on the most suitable registration procedure;
- Clinical Trial Applications;
- Consultation at any stage of drug development;
- Coordination with Regulatory Authorities prior and during the registration;
- Qualified person for importation of study drugs.
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Anna Lyutina,
Clinical Research Associate |
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Synergy Research Group (SynRG™) is an emerging CRO successfully assisting both pharmaceutical and biotechnology clients in conducting clinical trials in Russia and CIS countries.
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