Director
Drug Discovery & Development
Extensive experience in leading discovery projects, designing novel compounds, and accelerating early-stage drug candidates.
Synthesis of Complex Organic Molecules
Specialization in designing and synthesizing diverse compound libraries for pharmaceutical research.
Impurity Profiling & Reference Standards
Expertise in synthesizing and characterizing pharmacopoeial/non-pharmacopoeial impurities, reference standards, and working standards.
Process Development & Optimization
Skilled in feasibility studies, process optimization, and developing cost-effective, scalable synthetic routes.
Technology Transfer & Manufacturing Support
Proven ability to transfer processes from R&D to commercial-scale manufacturing with high efficiency.
Analytical Characterization & Structure Elucidation
Advanced knowledge in isolating, characterizing, and elucidating complex process- and formulation-related impurities.
Director & CMO
Publication
His publication in journals like Journal of Pharmaceutical and Biomedical Sciences
.
Regulatory Approvals & Compliance
Contributed to the successful ANDA and DMF approvals for global markets, including the US, EU, Brazil, and India. Well-versed in regulatory requirements for US FDA, EMA, and other international agencies.
Nitrosamine Impurity Analysis
Specialized in method development and validation of nitrosamine impurities in drug substances and products using LC-MS/MS and GC-MS/MS for sartan and non-sartan molecules.
Analytical Method Development & Validation
Expertise in method development, validation, transfer, and QC support, ensuring cGMP compliance and regulatory readiness.
Leadership & Team Management
Proven ability to lead large analytical teams, manage projects efficiently, and handle regulatory queries to drive successful drug approvals.