BioClinAarc provide regulatory consulting services to our all customer and work in consultation with them to develop customized regulatory strategies to expedite the regulatory review and approval process across Asia Pacific region. We provide solutions, advice, guidance and support to the global life science industry with a focus on regulatory affairs and innovation.
Our Regulatory Services Include:
Phase II, III and IV clinical trials approvals for drugs
Import licenses for investigational products, ancillary supplies and equipment
Export licenses for biologicals
Marketing authorizations for drugs
Site and product registrations for drugs and devices
Prepare and coordinate for New Drugs Advisory Committee (NDAC) and Medical Device
Advisory Committee (MDAC) at Drugs Controller General India (DCGI) Office
We can advise sponsors with judicious planning, development, analysis, and composition of regulatory submissions at all stages of development and post-marketing.
This section of our website will enable you to learn more about becoming an BioClinAarc Investigator and also provides a dedicated resource centre for Investigators working with BioClinAarc Central Laboratories.
