License Holder
As a proven medical device Regulatory consulting firm, for nearly a decade, Biostat has been setting the industry standards in assisting Medical Device and IVD companies worldwide for end-to-end Regulatory needs and product registration.
Biostat provides end-to-end Product Categorization Services, Product as well as Authorised Agent Services to all importers and manufactures of Medical Devices & IVDs. Our service offerings will help you import, manufacture, test, conduct clinical trials and distribute your products in India (Market Authorization), efficiently so as to achieve faster product approvals leading to enhanced access to Markets and Opportunities. we design and implement efficient and effective regulatory and product.
We provides complete support for Regulatory Consulting, Regulatory Strategy, Preclinical Study Approvals, Clinical Study Approvals, Market Authorization’s, Labelling Services, Regulatory Submissions, Regulatory Reporting, Regulatory Intelligence, Authorized Agent Services.