Regulatory Services provided by the CRO’s in India

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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