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Fixed Dose Combinations
Vyomus Consulting is a regulatory and development partner helping biopharmaceutical companies commercialize Biologics and Biosimilars, be it APIs or finished formulations in India. From discovery to commercialization, we design and implement efficient and effective regulatory and product development solutions which integrate science, regulations and business objectives, to overcome product commercialisation challenges.
Any regulated medicinal product which is to be imported, manufactured, stored, distributed, tested or sold in India, has to be registered with the licensing authority, Central Drugs Standard Control Organization (CDSCO) or specific State Licensing Authorities through various procedures.
CDSCO designates a product as a fixed dose combination(FDC) :
- When the product has two or more drugs, individually approved earlier for certain claimsare now proposed to be combined for the first time in a fixed ratio,
- When the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration.
Vyomus Consulting provides end-to-end Product Registration Services as well as Authorised Agent Services to all importers and manufactures of FDC products. Our service offerings will help you import, manufacture, test, conduct clinical trials and distribute your products in India (Market Authorisation), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities.
Our senior practitioners have a unique blend of business, science, regulations and technology expertise and include experts in product development, regulatory affairs, pharmacology, toxicology, preclinical and clinical trial design and evaluation, biostatistics, each with extensive product commercialisation experience.
Regulatory Consulting, Regulatory Strategy, Preclinical Study Approvals, Clinical Study Approvals, Market Authorisations, Labelling Services, Regulatory Submissions, Regulatory Reporting, Regulatory Intelligence, Authorised Agent Services.