Analytical Development
CoreRx™ formulation development and clinical manufacturing efforts are fully supported by our in-house analytical development laboratories. Equipped with state of the art analytical instruments, CoreRx analytical development provides services in support of pre-formulation, formulation, drug product performance testing, and clinical release testing for oral delivery (tablets, capsules, orally disintegrating tablets (ODT), and softgels), parenteral, ophthalmic, topical, and novel dosage forms for small molecules. Fully compliant with cGMP/GLPs, CoreRx can help you through NDA & ANDA submissions.
Representative Analytical Method Development Services
- Preformulation
- Salt Selection & Polymorph Screening
- Compatibility Studies
- Method Transfer & Evaluation
- Method Optimization
- Method Development
- Phase 1-3 Level Method Validation
- Product Analysis (physical & chemical)
- Stability Studies
- ICH Storage
- Impurity Identification