Regulatory strategy review and product evaluation is critical during a product’s life-cycle. During Phase IV, many companies plan on expanding the drug product indications, label claims and dosage forms through additional clinical trials. In addition, CMC changes including drug substance synthetic process, in-process controls, drug product composition, drug product manufacturing processes, specifications and acceptance criteria are continually refined post-approval with the goal of incorporating efficiencies and synergies.

We strategize and support post-approval changes including authoring and review of post-approval supplements (PAS, CBE-30, CBE-0 and annual reports).