New Drug Approval
Faster Approvals Leading to Enhanced Access to Markets !
Any drug including bulk drug substance which have not been used in the country to any significant extent and has not been recognized as effective and safe by the Indian licensing authority (CDSCO) are considered as New Drugs. All activities with reference to a New Drug, including Import, Manufacturing, Testing, Conduct of Clinical Trials, Marketing etc., have to be approved by the Central Drug Regulator – CDSCO. One category of “New Drug” encompasses all biological products including vaccines, biosimilars, rDNA Derived Products etc.,
In brief, there is a set procedure of application submission, review and approvals from various stakeholders that are required to initiate any and all activities indicated. The approvals are usually in the form of No Objection Certificates/Letters, Approval Letters, Licences etc.,
Vyomus Consulting provides both New Drug Registration Services and Authorised Agent Services to all categories of New Drugs in India. An end-to-end service offering which will help you import, manufacture, test, conduct clinical trials and sell your product in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
This service offering includes 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 New Drug 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
- 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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