Narcotics: Extended complete Regulatory & logistic support pan India to first Global Clinical Trial (GCT) with an imported narcotic IP. Product successfully launched in US and EU.
HCT: Conceived innovative regulatory pathway to bring to India a Human Cell & Tissue based product ensuring GXP Compliance including providing commercial incubator services.
Phyto-pharmaceuticals: Provided creative regulatory strategy and scientific consultation services (SEC) to facilitate the quality, speedy approval of a phyto-pharmaceutical product, for the first time in India.
Medical devices: Applying creative regulatory solutions to garner waiver of Clinical Trial & ensured market access of an innovative medical device product, for the first time in India.
Super Generic API Technology: Provided End-to-end technical project management including GXP compliance for technology transfer from US to India, to support global filings.
Established greenfield EU Approved manufacturing Site: Engaged to provide End-to-end technical project management including GXP compliance with regulatory approvals for a medical device manufacturing facility in India.
Nutraceuticals: Negotiated to navigate with agency consensus implementation of new guidelines for Nutraceuticals. Provided incubator platform including techno-commercial support to facilitate India launch.
Pharmacovigilance: Supporting post approval compliance for innovative products approved for marketing authorization with Post marketing studies, and medico-marketing for ethical promotions.