Nova(Shanghai)Pharmaceutical Co.,Ltd
Classification
Process R&D 

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

 

 

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