Regulatory Affairs

Regulatory Affairs develops and maintains the US FDA Investigational New Drug application (IND) required for drug delivery products in which the drug is responsible for the primary mode of action. Capabilities include IND creation, amendments and maintenance, leading FDA meetings and correspondence (e.g., Pre-IND Meetings), filing IND annual reports, and developing regulatory strategies for drug delivery products. 4P can hold the IND as the sponsor or perform transferred obligations in a support role.