API Process Development Services

Raleigh Molecular is an excellent contract partner for your API Process Development needs. We are FDA Inspected and Health Canada approved, offering integrated process development, API manufacturing, and finished dose manufacturing all in one location. With the expertise needed to develop a robust, transferable, and scalable process tailored to your needs, we leverage 30 years of experience to deliver fully integrated solutions emphasizing quality, speed, and flexibility.

Our API 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 provide comprehensive support to clients in all facets of API Process Development, encompassing process and analytical R&D, stability studies, impurity/degradant profiles, and raw material sourcing. Raleigh Molecular recognizes the importance of efficient outsourcing solutions in process development and is dedicated to streamlining timelines and costs across all stages of development and manufacturing.

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