FASTER PRODUCT APPROVALS LEADING TO ENHANCED MARKET ACCESS !
In India, food operators including importers of food and food additives are regulated through Food Safety and Standards Act, 2006, and the Food Safety and Standards Regulation 2011. This is a regulation to consolidate the laws relating to food and to establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import, to ensure availability of safe and wholesome food for human consumption. Based on this regulation, it is mandatory for all Food Business Operators in the country to be registered or licensed in accordance with the procedures laid down in the said regulation.
Also, 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.,
Optimus is a complete product development partner for importers, marketers and companies developing and commercializing food products. From discovery to commercialization, we design, implement and provide “Science Based Optimal Business Solutions” specifically tailored to overcome Regulatory & Technology based Product Development Challenges.
Optimus provides end-to-end Product Registration Services as well as Authorised Agent Services to all importers and manufactures of veterinary products. This end-to-end service offering will help you import, manufacture, test, and distribute your 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.
Optimus senior practitioners have a unique blend of business, domain, technology and pharma process outsourcing expertise and include former senior executives from top Pharma, Biotechnology, 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, preclinical 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
- 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.,