Submission Strategy:
Determining feasibility on clinical programs in line with product development. Writing clinical development plans and synopses for Phase I-III trials. Reviewing completed studies with unexpected results to provide solutions and strategies for the way forward. Advising clients on submission strategy, study design and studies required for regulatory submission, e.g. TPD, FDA, EU and other regulatory bodies and liaising with these regulatory bodies on study requirements for specific compounds. Providing expertise on requirements for submission in Europe.
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The need to be able to explain the outcome of a study with unexpected results before submission is important to many pharmaceutical companies to ensure a successful regulatory assessment. Study results do not usually come out as clear pass or fail. Why does the AUC meet BE criteria and not the AUC infinity for a phase BA/BE study? Why does a test drug have similar efficacy to a placebo? How do you explain a test formulation that shows higher systemic levels to the reference formulation or demonstrate how a generic formulation is slightly more efficacious than the brand product in a clinical endpoint study? HT Pharmaceuticals will review results and provide a clear way forward before submission.
