Gilead’s Captisol-enabled Remdesivir Approved for Use in Renally Impaired Patients
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Collaboration Support
Collectively, the Captisol Team has over 80 years of experience in drug development, from preclinical through Phase IV (post commercial) clinical studies. Evomela, Nexterone, and Fosphenytoin are three examples of Captisol enabled drug products that the Captisol team has successfully brought forward. We have also assisted clients in numerous development projects.
Our team has extensive knowledge in the areas of prelicinical, CMC, and clincal development, orphan designations, ANDA, 505b2, biowaivers, and traditional NDA submissions. We can help with product formulation projects, assist in development of safety studies, regulatory strategies, and manufacturing processes. We have helped many organizations including big pharma companies, academic groups, non-profit organizations, small biotech firms, etc. Please find a list of services below.
Consultant Services
- Manufacturing Support Services
- Evaluation of Cyclodextrin Containing Formulation
- Clinical Trial Planning Consultation
- Regulatory Affairs Consultation
Lab Contract Services
- Solubility and Stability Evaluation
- Pre-Formulation / Feasibility Assessment
- Formulation Development
- Custom Synthesis (Lab Scale)
- Cyclodextrin Derivatives
- Drug / Cyclodextrin Mixtures
Contact us today to discuss your needs!
