Regulatory Services provided by the CRO’s in India
Most Clinical Research Organizations in India offer regulatory services in all the levels of Phase I to Phase IV studies and other medical researches including bioavailability and bioequivalence studies. This is also offered at multiple stages of drug development too and can be attained by giving interdisciplinary planning that result in high quality of regulatory method for regulatory authorizations.
A Clinical Research Organization, i.e. CRO in India makes use of its able medical technicians and professionals and applies this field of knowledge to various medical projects. At the same time, there are numerous expert teams having the capability of handling a wide range of regulatory services and enables sponsors to cater to exigent timelines. In addition to that, CRO’s help in attaining regulatory approvals owing to their understanding and experience in the Indian clinical regulation and policies.
In the recent past, the Indian sub continent has gained prominence as a center for medical tourism, Phase 1 studies, medical trials and researches that are conducted by multinational pharmaceutical companies. The primary reason being high end healthcare options, advanced devices, effective and quality diagnosis and a group of expert medical professionals.
CRO’s and Regulatory Services
Prominent CRO’s in India, offer regulatory services and QA that consists of essential elements of the service portfolio that is provided to the mass at large. There is a dedicated team assigned for audit and regulatory compliance and are generally backed up by the knowledge of local regulatory procedures. At the same time, they are an appropriate association with the multiple regulatory agencies that assures competence in the clinical trial approval process.
Selected regulatory services provided by the CRO’s in India are as follows:-
* Compilation of the clinical trial application
* Obtaining approvals for conduct of clinical trials
* Procurement of drug import licenses
* Renewal of Import License
* Formulation of regulatory strategies
* Submission of Clinical Safety Report (CSR)
* Submission and follow-up of the application
* Safety Reporting
* Procurement of NOC for export of biological samples
* Tracking of applications and approvals
* Response to regulatory agency queries
Apart from these regulatory services CRO’s offer a clinical laboratory that is the backbone of all medical researches and studies and is helps in various processes for disease treatment and drug development.
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