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

Essentials of Auditing in the Manufacturing of Cell and Gene Therapies

Auditing in manufacturing of cell and gene therapies

Our previous posts on quality management systems and steps to ensure your cell and gene therapy (CGT) product is Good Manufacturing Practices (GMP) compliant alluded to auditing in the context of a larger manufacturing workflow. This post provides useful insights into auditing to help clients and contract manufacturing organizations (CMOs) understand this critical aspect.

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Posted: Mar 27, 2020 9:56:27 AM