DHC’s strategic design of the comparability package and tech writing for the regulatory submission allowed for a quick and cost-effective proof of equivalence. The comparability submissions were accepted by global regulators with limited questions, resulting in delay-free implementation of the improved manufacturing methods in multiple global jurisdictions.
In this case, the client was implementing two manufacturing changes (detailed below) while simultaneously preparing to open a multi-jurisdictional clinical trial.
Various considerations including time, cost, and feasibility constrained available study designs to demonstrateequivalency between the old and new processes. DHC worked with the client to design the comparability study plan, analyze the resulting study data, and write up the study findings for submission to global regulators.