Regulatory Science & Product Development Experts helping customers
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Vyomus Consulting is a regulatory and development partner helping biopharmaceutical companies commercialize Blood and Blood 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.
Human blood is covered under the definition of a ‘Drug’ under the Drugs & Cosmetics Act. Hence, requirements for collection, storage, processing and distribution of whole human blood, human blood components by blood banks and manufacture of Blood Products are highly regulated in India.
“Blood” is defined to include whole human blood, drawn from a donor and mixed with an anti-coagulant; a “Blood Bank” is defined as a place or organization or unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components; a “Blood Component” means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor; and a “Blood Product” is defined as a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors.
In brief, 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.
Vyomus Consulting provides end-to-end Product Registration Services as well as Authorised Agent Services to all importers and manufactures of Blood 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.