CDMO Blog

When and How to Engage with Your Regulator

Regulatory meeting attendees shaking hands

Whether you are developing a therapeutic or an enabling technology, you know that ambiguity can be one of the biggest hurdles to overcome in early development and can slow down or even stall decision making. One way to reduce ambiguity, and therefore risk, is to consult with regulators on your planned development activities. Companies may engage with Health Canada, U.S. Food and Drug Administration (FDA), European Medicines Association (EMA) or other global regulators as part of this process.

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Posted: Jun 8, 2020 11:00:07 AM