Apozeal Pharmaceuticals is available for end-end pharmaceutical development consultation to the pharmaceutical industry. We can advise you on the best available development options to expedite the start of First in Human (FIH) clinical trials. These strategies are based on the drug substance properties such as form, solubility and bioavailability and BCS classification. We can provide you with various alternatives to develop poorly soluble molecules as well for phase 1 clinical trials and how to develop phase appropriate drug product for phase 2 clinical trials. Drug product formulation & process needs to be carefully selected in phase 2 and pivotal trials based on the commercial QTPP in sight. A robust formulation and process are very important at this stage in the drug product development.

We can also assist you with commercial drug product manufacturing site selection, site-specific-stability, registrational stability, timing of process validation (PPQ), launch supplies, and continued process verification (CPV) requirements from various global health agencies to deliver the product to patients worldwide in unmet medical areas.