October 19, 2017

Consulting Services

Using our expertise and over two decades of broad hands-on experience in organic synthesis, process chemistry, crystallization development and biocatalysis, as well as the management of outsourced chemistry R&D projects for the production of APIs for preclinical and clinical evaluation (Phase I – III), we provide tailored consulting services in the following areas:

Chemical Development and Process Chemistry:

  • Synthesis route, process scouting and selection
  • Phase appropriate process development and optimization for APIs
  • CMC development strategies to remove bottlenecks in drug substance procurement
  • Design of robust crystallization processes for physical form control and particle engineering
  • Technology transfer – documentation, management, and implementation

Salt, co-Crystal, Polymorph Screening and Selection:

  • Approaches to rapid screening and selection of developable forms of APIs
  • Characterization of polymorphs
  • Expert witnessing

Problem Solving:

  • Troubleshooting problematic synthesis and process steps
  • Troubleshooting crystallization processes, resolving issues of polymorph control and other particle properties to achieve specifications

Technical Writing:

  • Drafting, reviewing and editing chemical development reports
  • Drafting, reviewing and editing CMC section of regulatory filing dossiers (IND, NDA, IMPD)
  • Drafting, reviewing and editing batch records for the manufacture of APIs

Additionally, OKAPI Chemtech closely works with a multidisciplinary network of Consultants whose expertise is widely recognized in the industry.