Regulatory Development Strategy
Early preparation of a regulatory strategy is important to an effective development program. To define a projects objectives and outcomes provides a goal that all team members can focus on. Without understanding the regulatory pathway can result in studies being undertaken that are not critical to a products success.
Accelagen get involved in the development path at an early stage, and can being the foundations of a robust regulatory strategy that can result in a pave the way forward to achieve the end goal. The team draws on prior experience and existing data to help develop a regulatory pathway, including identifying the types of data required, suggested study designs and key decision milestones. We then present these plans in a concise and effective manner, amending and revising as new data or observations come through to ensure it remains contemporary.