API Process Development Services

Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location. We have all the expertise required for developing a process that is robust, transferable, and scalable to meet your requirements. We bring 30 years of experience to every project and deliver fully integrated solutions with an emphasis on quality, speed, and flexibility.

API Process Development Services

Our Process Development and Manufacturing Services include:

  • Custom Synthesis from mg to multi-kilogram scale in batch (up to 300L reactors) or continuous process
  • Optimization of existing synthetic routes
  • Development of GMP friendly alternative synthetic routes
  • Development of IP protected synthetic routes
  • Statistical Design of Experiments (DoE) for process parameterization and optimization
  • Development and optimization of purification and isolation methods
  • Isolation of active ingredients from natural sources
  • Transfer of process into GMP
  • Troubleshooting
  • Polymorphism study
  • Documentation of CMC development projects
We support clients in all aspects of API Process Development, including process and analytical R&D, stability studies, impurity/degradant profiles, and raw material sourcing. Dalton understands your need for efficient outsourcing solutions in process development and is focussed on reducing timelines and costs throughout all phases of development and manufacturing.