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Clinical Study Approvals
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, Pharmacovigilance studies etc., have to be approved by Ethics Committees and the Indian drug regulator, CDSCO.
In case there is a requirement for import and or export of clinical trial supplies and or biological samples, appropriate licences from appropriate regulators 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,including payment of compensation, according to a clearly defined responsibility matrix.
Vyomus Consulting provides efficient and effective Clinical Study Approvals, Product Registration Services and Authorized Agent Services to all categories of regulated products indicated above. An end-to-end service offering that will help you import and market your products in India efficiently through faster product approvals leading to enhanced access to Markets and Opportunities.
Vyomus Consulting provides end-to-end services in this service segment – starting from protocol preparation of various clinical study documents – both essential and non-essential, clinical stusy documents review, CRO identification, selection and qualification, various stakeholder regulatory submissions, study approvals management, study regulatory obligations, pre study and post study audits, study related regulatory reporting, study report review and final study report submission to the regulator.
Vyomus Consulting also provides end-to-end Ethics Committee (Institutional, Independent, Academic) Registration Services. This includes services right from helping in member identification, selection, developing approvable Standard Operating Procedures, dossier submission, Independent Audits and Approval Management.
Product Category -> Regulatory Agency -> Appropriate Application Procedure -> Regulatory Review -> Query & Resolution -> Market Authorisation -> Market in India.
Industry focus :Pharmaceuticals, Medical Devices, Cosmetics & Wellnes, Food & Nutrition.
- Prepare, review, submit, obtain and maintain Market Authorisations for the following medicinal products at CDSCO : Pharmaceuticals, Medical Devices & IVDs, Cosmetics, Biologics & Biosimilars, rDNA products, Phyto Pharmaceuticals, Blood & Blood Products, Veterinary products, Ayurvedic products, Vaccines, Generics, Fixed Dose Combinations etc.,
- Prepare, review, submit, obtain and maintain Clinical Study Approvals for Cosmetics products.
- Prepare, review, submit, obtain and maintain Clinical Study Approvals for the following food products at FSSAI : Food, Health supplements, Nutraceuticals, Foods for special dietary use, Foods for special medical purpose, Nutritional ingredients, Genetically modified food, Food with prebiotics, Food with probiotics, Organic Foods, Functional food, Proprietary food, Novel foods etc.,.
- Act as your India Regulatory Department for maintaining required licenses and provide post authorisation support such as Complaint handling, Adverse incident Reporting & Management and product recall support as part of Product safety reporting, Query management, PSUR Writing & Submission activities.
