including CMC variations, package insert safety updates, new indications, technical changes to the label or the in line with registration plan. Time to register new products vs. target and vs. industry norm. Extent submissions. Ensure responses to recommendations for new products and indications are responded to timeously compilation and submission of variations, application for new products and life cycle maintenance in accordance
regulatory strategies, processes, and plans in support of new registrations and post-approval submissions. To ensure