Masuu support scientific package preparation to take scientific advice from the agency panel of experts regarding development, manufacturing, controls, non-clinical, clinical and other aspects of the development strategy.
Our specialized team excels in crafting tailored scientific packages designed to support regulatory submissions. The pharmaceutical companies, upon securing approval for their products from a global health authority, can optimize the regulatory filing process through our scientific package preparation approach. This approach enables expedited submissions to additional regulatory bodies by providing a dossier filing rationale without the need for duplicative bioavailability/bioequivalence (BA/BE) studies. Instead, our approach incorporates a bridging study, dissolution justification, and method validation verifications and transfers, allowing for the efficient reuse of approved documentation.