CMC: Chemical, Bio & Fermentation, Drug Product & Analytical Development
Overview
The Rondaxe team of development experts has experience in every aspect of the industry.
In addition to small molecule drug substance development, Rondaxe has extensive experience in biological and fermentation technologies, including strain engineering and recombinant proteinexpression for fermentation and biotransformation.
Our drug product team has wide experience in formulation process development, scale up, and commercialization of sterile, oral solid, ophthalmic, topical and veterinary products.
Our analytical development team has comprehensive methods development and validation experience.
Services
- Synthetic Route Strategy Development
- Synthetic Route Selection
- Regulatory Starting Material Definition
- IPC & PAT Method Development
- Strain Selection
- Feed and Media Optimization
- Protein Fermentation & Purification
- Biocatalysis Strategy Development
- Analytical Strategy Development
- Analytical Testing/Validation
- Formulation Development
- Excipients/Ingredient Selection
- Drug Product Analytical Methods Development
- Report Documentation
Benefits
- Solutions for all aspects of your development needs
- Access to our highly experienced industry team