Ask the Regulatory Experts

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?

Inspections by FDA are on the rise. How can one best prepare?

Can you offer any best practices for change management?

How important is it to respond to an FDA–483 within 15 days?