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Regulatory Advice services

Regulatory Advice Service

 
Veeda Clinical Research® has dedicated resources which enable us to provide regulatory solutions to support our clients’ product development programs. We can also provide on-going regulatory support once your product is registered.

Our broad functional and therapeutic area expertise enables us to provide specialised inputs to clients according to their needs. We have substantial experience in Europe, the US and India.
 
Regulatory Strategy input to the Product Development Plan.
Bioavailability/Bioequivalence/Food Effect of Veeda Clinical Research
Preparation of Clinical Trial & Ethics Committee applications and on-going support for trials including Safety Reporting.
Drug Interaction
Preparation of Product Registration applications, Drug Masterfiles and Post –approval regulatory submissions (renewals, variations, defence documentation).
Proof of Concept
Project Management and co-ordination of registration applications including interfacing with Regulatory Authorities on behalf of clients.
Proof of Concept
Provision of Clinical, Quality and Safety (CQS) Expert Reports and Summaries.
Proof of Concept
Manufacturing Change Control.
Proof of Concept
Training programmes for the EU Clinical Trials Directive.
 
Please click on the below for more information on Regulatory Affairs.
 
Regulatory Affairs: Malaysia vs India vs UK
Regulatory Submission process in India for Phase I /BA-BE
Documents Required for Submitting an Application to DCGI
Webinar on India Regulatory Affairs
Regulatory Presentation -
 
To know more about Veeda services or if you have any query please click here to contact us
 
To know more how veeda’s expertise and experience for Regulatory Advice Service can help you, please be in touch with us using this form
 
Phase 1 clinical trials,Phase I/IIa studies,ECG Studies
Clinical Trials, India,Indian CRO,Phase 1 clinical trials,Bioequivalence
 
 
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Veeda Clinical Research and Veeda Oncology are registered trademarks of Veeda Clinical Research, Inc.
   
 
Ver. 1.76 (Last Updated - 30 June 2010)