Faster Product approvals Leading to enhanced Market Access !
Indian Regulatory definition of Nutraceuticals – a naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease, isolated and purified from food or non-food source and may be prepared and marketed in the food-format of granules, powder, tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc and to be taken as measured unit quantities.
The Nutraceutical industry in India is one of the rapid growing markets and divided into three segments – functional food, functional beverages and dietary supplements and regulated under Food Safety and Standards Act of India (FSSAI), 2006.
Vyomus is a complete product pipeline development partner for Nutraceutical product companies which develop and or commercialize Nutraceutical products in India. From discovery to commercialization, we design, implement and provide “Science Based Optimal Business Solutions” specifically tailored to overcome Regulatory, Technology and Market based Product Development Challenges.
In general, any regulated product which is to be imported, manufactured, stored, distributed, tested or sold in India, has to be registered with the licensing authority (FSSAI) through various procedures. Products tested or sold in India, could be manufactured locally or can be manufactured outside India but Imported for sale or testing into India. Any manufacturer who wishes to import and market products manufactured outside of India, should register the products which they propose to import for sale.
Vyomus provides end-to-end Product Registration Services to all importers and manufacturers of Nutraceutical products. This end-to-end service offering will help you import, manufacture, test and distribute your products in India (Market Authorization), 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.
Vyomus senior practitioners have a unique blend of business, domain, technology and pharma process outsourcing expertise and include former senior executives from top Pharma, Biotechnology, Food, Clinical Development companies, top tier consultancies, Fortune 500 enterprises, and leading outsourcing service providers. Our team consists of experts in product development, regulatory affairs, pharmacology, toxicology, pre clinical and clinical trial design and evaluation, biostatistics, each with extensive product development experience.
We are thus able to provide regulatory consulting and product development services through all stages of product development to enhance the probability of success and achieve faster product approvals leading to enhanced access to Markets and Opportunities.
Our services include the following:
- Regulatory Strategy Consulting and Liaison for Nutraceuticals
- 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 for Nutraceutical Products by Applying and Maintaining required approvals, Prepare and review regulatory submission material for compliance to India legislation etc.,
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