Ask the Regulatory Experts

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We regularly publish a regulation and compliance Q&A with former FDA officials now consulting at Parexel. Where do these questions come from? You, the readers.

PharmTech regularly publishes common Q&As regarding the regulation and compliance of pharmaceutical development and manufacturing. Questions are answered by former FDA officials, now in consulting roles.

Questions can be sent to All names/submissions will be kept anonymous.

Alternatively, questions can be posted on our LinkedIn Group or sent to us on Twitter @PharmtechGroup.

You can read some of the past Q&As here. We’d love to hear your comments on the advice. Is it useful? Do you have any follow up questions?