Azbil Telstar India Pvt Ltd.; a Japanese Spanish Conglomerate, dedicated for the Life Science Industry development. We are into development of complete integrated engineering, construction, equipment and services solutions for life sciences (pharmaceutical and biotechnological industry, hospitals, laboratories and research centres).

Along with this we are also offering “Third Party Quality Audit services” for customers who are sourcing Raw materials (Generics, API, key starting material, intermediates and Excipients) Packaging Material, Product (Sterile and non- sterile forms) from different geographical regions.

We have done quality auditing of 500 Pharmaceutical sites in a span of 5 years on behalf of our European customers, who want to source API/Formulations/ Medicinal product from India. We have Pool of dedicated auditors who could perform quality audits against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more.

For your ready reference here we enclosed list of components that we do:

·         Quality Audit for Raw materials (API and Excipients), Packaging Material, Product (Sterile and non- sterile forms), Current Good Manufacturing Practices (cGMP) as per ISO 9001:2008 standards

·         Consultancy for compliance with GXP and ISO standards

·         Consultancy for the registration of new products and the approval of variations

·         Preparing registration documents (DMFs and CEPs)

·         Manageme