Clinical Research and Pharmaceutical Regulatory Affairs

 

Regulatory handling of Clinical Research is quite crucial as without the approval all efforts stand null and void. Officially a research not made on par with Regulatory requirement and not licensed or approved by Regulatory Authorities serves no good. Organizers always try to put their maximum effort to follow lines with rules and regulation of global standards. In absence of universal regulations sometimes process gets complex for sponsors and organizers of the study. The different countries licensing process may vary on different lines that can go beyond comprehension of foreign sponsors and organizers conducting study in subject country.

 

CRO or Contract Research Organization here proves to be great assistance for sponsors as they have the country origination and have good rapport with regulatory process and authorities. These CRO can look into all ethical consideration related to Clinical Research and study on par with global standards. In different steps of Clinical Trials, CROs help you achieve regulatory approval in the country with well written regulatory documentation.

 

With CROs expertise, sponsors can feel free for the following aspects of Clinical & Pharmaceutical Research Regulatory Affairs-

• Registration of foreign manufacturing plants and drugs including API, Formulation (including vaccines, rDNA products, blood products), Medical devices and Diagnostics kits
• New drug approval for API, Formulation, Medical devices & Diagnostics kits
• Clinical Trial Approval for Phase I for Indian Discovery, Repeated Phase I, Phase II, Phase III and Phase IV
• Safety Reports Updating
• Import Licenses and permits for commercial and experimental use
• No Objection Certificate for conducting BA/BE studies
• Export permission/permit for Biological Samples from Directorate General of Foreign Trade,/Ministry of Commerce
• Clinical Trial Protocol Amendments Approval
• No Objection Certificate for export of Unapproved/Banned drugs