- Decades of experience in bringing new API from discovery to clinic and to registration
- Intimately familiar with all regulatory and quality requirements.
- Phase-appropriate development approach
- Process development is guided by “quality, safety, and efficiency by design”
- Project teams comprising the required expertise in chemistry, analytics, manufacturing and quality assurance.
- Manufacture of APIs for preclinical, clinical, and commercial use.
- State-of-the-art manufacturing facilities suitable for gram to tens of kgs.
- High-containment facilities suitable for highly potent substances such as hormones and cytotoxics.
- Purification technologies including column chromatography, and preparative HPLC, ion exchange chromatography, and ultra- and nanofiltration.