Drug Substances

  • 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.

 

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