Faster Approvals Leading to Enhanced Access to Markets !
In order to legally import and market diagnostic and In-Vitro Diagnostic device/s in India, a manufacturer needs to be compliant to Indian regulations and legislation. At present, certain “notified” diagnostics and In-Vitro Diagnostic (IVD) Devices are regulated under the provisions of the Drugs and Cosmetics Acts & Rules.
In brief, there is a set procedure of application submission, product testing, registration dossier submission, review and approvals from various stakeholders that are required to facilitate Product Approval / Market Authorisation. The approvals are usually in the form of No Objection Certificates/Letters, Approval Letters, Licences etc.,
Vyomus Consulting provides end-to-end Diagnostic / IVD Product Registration / Market Authorisation Services as well as Authorised Agent Services to all importers and manufactures of diagnostic products. This end-to-end service offering will help you import, manufacture, test, conduct clinical trials and distribute your diagnostic products in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
This service offering includes Product Testing Vendor Identification & Management, various stakeholder regulatory submissions, approvals management, independent audit, regulatory reporting, regulatory dossier review and submission to the regulator.
Our services include the following :
- Regulatory Strategy Consulting and Liaison
- Complete Product Life Cycle Management
- Compilation of India specific submission dossiers
- Submission management leading to approvals from ALL Stakeholders
- 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
- All statutory Marketing Authorization holder’s requirements
- Act as your India Regulatory Department by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,
Discuss Your Needs
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