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Emergence of Systematic Regulatory Services

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					                         Emergence of Systematic Regulatory Services

Owing to the occurrence of chronic ailments, India has risen up to it by developing its present treatment
modalities and drug development process. In keeping with the developments, India in the recent past
have gained the titled of one of the most “preferred hub” for medical tourism. Innovative and advanced
medical studies and researches for finding out better cures and treatment needs a systematic research
and development process and regulatory policies that ensure the quality of clinical trials and trial
output.


This cause has made numerous Indian CRO’s (clinical research organization) come up with high-end
clinical laboratory services that helps in better disease treatment and systematic drug development.
The medical technicians and doctors today carry on medical researches and medical studies along with
assessing human blood samples, to evaluate the availability of the active drug in blood and the period
of availability of active drug in blood which helps to decide the dosage schedule for the patient. Apart
from this CRO’s also give emphasis on regulatory compliance and proper quality assurance. Most Indian
CRO’s have a dedicated team for regulatory services as well as audit compliance that is backed up by a
vast know-how on the local regulatory processes and meaningful liaison with other regulatory agencies
thereby assuring accuracy in the clinical trail approval procedure.


Indian CRO’s that specialize in regulatory services has efficiently conducted multiple audits in numerous
Indian and global regulatory agencies. In addition to that, they have also researched on the study
submission from various countries. The host of regulatory services provided by Indian CRO’s is:


    ●     Formulating regulatory strategies
    ●     Replying regulatory agency queries
    ●     Renewing Import License
    ●     Procuring drug import licenses
    ●     Follow-up and submissions on the application
    ●     Tracking applications and approvals
    ●     Submission of Clinical Safety Report (CSR)
    ●     Safety Reporting
    ●     Procuring NOC for export of biological samples
    ●   Compiling a clinical trial application


This apart, concerning regulatory policies and quality assurance the Indian CRO’s also have their
own quality assurance team to manage the medical practices with quality. This team concentrates
on the quality that goes through the procedures within the domain of every single medical process.
Furthermore, there are certain executions that are conducted by the Quality Control and Quality
Assurance procedures. The Quality Assurance practices generally spans across Bioanalytical and
Bioavailability studies, Statistics, Clinical, Internal Audits and Reporting by the QA team for any area
specific SOP compliance. There are other in-house capacities too that CRO’s conduct and it comprises
various aspects such as Site Audits, Vendor Audits, Process/System Audits, and Document.


Read More About: Clinical Pharmacokinetic, Biometrics

				
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Description: Indian CRO’s that specialize in regulatory services has efficiently conducted multiple audits in numerous Indian and global regulatory agencies. In addition to that, they have also researched on the study submission from various countries.