Biologics & Biosimilars
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 any Biologic or Biosimilar, including vaccines and Recombinant DNA (r-DNA) derived drugs,API’s or product’s as a New Drug.The procedures and processes for registering Biologics and Biosimilars are clearly defined and outlined under appropriate regulations and guidelines.
Vyomus Consulting provides end-to-end Product Registration Services as well as Authorised Agent Services to all importers and manufactures of Biologics and Biosimilars. 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.
