Pre-Marketing Authorization

Navigate the complex PMA process for FDA approval of your new drug or biotherapeutic with Inotiv's expert guidance, ensuring patient safety and a smoother path to market.

Confidently Reach your PMA Milestone with Inotiv as Your Partner

The Pre-Market Authorization (PMA) process is a rigorous and multi-step procedure by which drug companies seek approval from the Food and Drug Administration (FDA) to market either a new small molecule drug through a New Drug Application (NDA) or a biotherapeutic through a Biologics License Application (BLA) in the United States.

The PMA process is a lengthy and complex undertaking, often taking several years to complete. However, it’s a crucial step to ensure that new compounds are safe and effective for the intended use before they reach patients.

PMA Milestone with Inotiv as Your Partner

Inotiv’s PMA Supporting Services

Supporting a PMA requires a wide range of expertise across various scientific, regulatory, and logistical areas. Here’s a breakdown of some key services offered by Inotiv.