Real examples of our regulatory expertise and successful project outcomes
Discover how we've helped clients navigate complex regulatory challenges and achieve their goals
Regulatory support for ICMR sponsored clinical trial - Event-Driven, Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity, and Lot-to-Lot consistency of BBV152, a Whole virion Inactivated SARS-CoV-2 Vaccine in Adults greater than or equal to 18 Years of Age.
A Prospective, multicentre, Phase II Seamlessly Followed by Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological E's CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to COVID-19-Negative Adult Subjects.
Regulatory support for CAR-T Cell therapy to M/s Immuneel Therapeutics Private Limited for guidance on documents, filings from licenses to IND applications/approvals.
Agreement between Genomeks, a Genomics Division of Enviromax LLP, Hyderabad for Analyzing and preparing of Detailed Project Report (DPR) on the Emerging Cell and gene therapy business plan Landscape in India.
Collaboration with Deloitte USA with support from Department of State, USA, to host an event called "The India Biosecurity Fellow Program, a collaborative capacity building initiative. This three-day program marked a significant milestone as the first of its kind in India, training 15 young professionals.
Collaboration with Gryphon Scientific LLC, a US-based research consultancy organization working on global health and security to host an event called "Cybersecurity Needs for the Indian Biotechnology Sector" (In-person workshop) With funding from US Department of State Cooperative Threat Reduction Office.
Established MGM Clinical Trial & Training Centre (MGM-CTC) with infrastructure, human resource and data center. Coordinate the sponsored clinical trials both at MGMCRI and SSMCRI and other constituent college and centers.
Comprehensive training programs covering risk assessment, containment, decontamination, security protocols, and incident reporting for biological agents handling.
Clinical Trials Supported
Years of Experience
Publications
International Collaborations
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