A Guide Accross the Regulatory and Scientific TerrainBy Pharmaceutical Development Group
Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration (FDA).
In addition to all types of submission and milestone meetings, the company helps orchestrate the full range of communications such as orphan drug designation requests, requests for designation (drug, device, or biologic), and 513(g) submissions.
As industry experienced regulatory strategists, scientists, and business professionals, PDG is a true project manager, helping you request fast-track or breakthrough designations, managing priority or rolling reviews, and desining study protocols to fit accelerated approvals.
To find out more about PDG's services, including vendor sourcing, life cycle management, labelling, and clinical studies, download this free whitepaper.