Novapharmas' team is experienced in lots of organic chemistry reactions. We have many expert senior leaders with multiple years of experience working at major US and European Pharmaceutical companies.These leaders manager a staff of over 100 chemicsts(process, analytical , formulation)before joining Novapharmas, engineers, quality assure, and plant operational and support staff. Together , our staff ensure that all projects undertaken by us completed to the customer's satisfaction.
Process Research & Development Services include:
² ICH stability Studies
² CMC CTD Support
² Consult, assessment, and project management
² Route design, and scouting
² Process parameters optimization, cost reduction, critical parameter identification
² Technology transfer
² Process safety and risk assessment
² Suppliers inspection
² Salt screening, poly morph screening,
² Process development for crystallization
² Impurity profiling
² Impurity isolation and structure elucidation
² Reference standard qualification
² PGI method development, validation and testing
² Development, validation of analytical methods
² Stability tests
² Specification and regulatory filing documentation preparation.
² Manufacturing