Pharmaceuticals
Vyomus Consulting is a regulatory and development partner helping pharmaceutical and biopharmaceutical companies commercialize complex small-molecule APIs, finished formulations and biologic drug products 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.
In general, any pharmaceutical or medicinalproduct 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.
The procedures for registering products are also based on the nature of products (Chemical, Biologic, Plant origin etc.,) stage of manufacturing (Intermediates, API’s, Finished formulations, products ready for pack & fill etc.,), geographic location (manufactured in India or outside of India), intended use of the product (end use of the product), type of products(Old Drug, New Drug, Subsequent New Drug, Investigational New Drugs, Fixed Dose Combinations etc.,).
Vyomus Consulting provides end-to-end Product Registration Services as well as Authorised Agent Services to all importers and manufactures of Pharmaceuticals. 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.
