Welcome to Lynn Consulting: GxP Pharmaceutical Quality Compliance

From Regulator to Regulated

Real World - Real Experience

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The Journey Begins Now

Winding mountain road representing the pharmaceutical quality journey

Pharmaceutical Quality can be a winding road over a rocky mountain. We can help navigate your company in the right direction.

Executive leadership experience in the US FDA and in both generic and brand pharma means our company brings real world experience to the table. This type of experience can't be found in many companies.

Compliance remediation

Compliance Remediation

Every company has issues, that's OK. It's what you do about those issues that counts. Our FDA experience, accompanied by private sector compliance experience can help you put the right remediation strategy in place.

Pharmaceutical vials in production

Health Authority Inspection Responses

First, stay calm......it's time to step back, assess and reflect on the inspection experience and observations. Should you address the specific topic or should you go broader? We can help with this and help you with a thorough response. We've evaluated and acted upon numerous 483 and Warning Letter responses while at FDA. It's this type of experience that differentiates us from the competition.

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Have Questions? Need Help?

Please reach out to us with any questions.

Lynn Consulting, LLC

Silver Spring, Maryland, United States

Office: +1-301-460-6726

Mobile: +1-202-440-2478

[email protected]

"The bitterness of poor quality lingers long after the sweetness of low price is forgotten." — Benjamin Franklin