Clinical Study Approvals
Effecient Study Approvals Leading to Faster Turnarounds !
All clinical studies, including academic and commercial studies are strictly regulated in India. All phases of human clinical trials (Phases 1 to 4), specialty clinical studies, bioavailability and bioequivalent studies etc., have to be approved by Ethics Committees and the Indian drug regulator, CDSCO. In brief, there is a set procedure of submission, review and approvals from various stakeholders that are required to conduct a clinical study in India. The approvals are usually in the form of No Objection Certificates/Letters, Approval Letters, Licenses etc.,
In general, a clinical study has to be approved finally by the Indian Drug Regulator – CDSCO (Indian Drug Regulator). Before the final approval is rendered by the CDSCO, the protocol has to be reviewed and approved by a CDSCO approved Ethics Committee. In case there is a requirement for import and or export of clinical trial supplies and or biological samples, appropriate licences will have to be obtained. The study also needs to be constantly monitored and any safety issues in terms of clinical adverse events etc., has to be reported to the CDSCO within a stipulated time frame. Based on the nature of an adverse event, appropriate remedial actions will have to be initiated according to a clearly defined responsibility matrix.
Vyomus Consulting provides end-to-end services in this service segment – starting from protocol review, vendor identification & management, various stakeholder regulatory submissions, study approvals management, study regulatory obligations, study audit, study related regulatory reporting, study report review and final study report submission to the regulator.
Vyomus Consulting also provides end-to-end Ethics Committee CDSCO Registration Services. This includes services right from member identification, selection, developing approvable Standard Operating Procedures, dossier submission, Independent Audits and Approval Management.
Our services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete Clinical Study Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals from ALL Stakeholders (IEC, EC, CDSCO, DGFT, DAC’s etc.,)
- India Specific Labelling and Patient Information / Instructions for Use leaflets
- Post marketing services including Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities
- Act as your India Regulatory Department by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,
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