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Regulatory Compliance

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CRx is able to put together an experienced project team of subject-matter experts from our global pool of consultants to work alongside local teams on regulatory compliance cases.

Our regulatory experts stay up to date on current requirements and protocols in the often rapidly changing regulatory environment. With proven experience, we are able to gain compliance for our clients’ products under challenging conditions and faced with aggressive deadlines.

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  • Quality System Gap Analysis
  • Quality System Integration
  • Corrective Action Preventive Action (CAPA)
  • Root Cause Analysis
  • Complaint Investigation
  • Risk Management
  • Audit Responses
  • Regulatory Affairs Consulting

For streamlined, cost-efficient solutionsContact CRx

The True Cost of Non-Compliance


Companies often choose to delay large-scale compliance efforts due to a variety of factors. But are you aware of the true cost of non-compliance and the lasting negative impacts it can have on the success of your product and the long-term heath of your business?

At CRx Life Sciences we call this the “elephant in the boardroom.” But not talking about it ­ – and not taking action – will not make your non-compliance issues go away.

Contact CRx for streamlined cost-efficient compliance management and compliance remediation services.


Get Started

These hard questions need to be answered:
What phase of a non-compliance audit are we in?
Have we received notification in the form of a

  • Form 483
  • Warning letter
  • Consent decree
  • Removal of product from the EU due to Notified Body findings?

How did we get here?

  • Mergers and acquisitions (out of our control)
  • Organizational deficiencies (we should have planned for this)
  • Out of sight, out of mind attitude (we should have made this a priority)

What are the financial costs?
How much money would we need to spend to remediate, if forced, due to the above-mentioned notifications? What is the true cost when we factor in loss of potential revenue from sales in the US and abroad?
What are the costs in time and loss of reputation?
What will it take to proactively pursue remediation and save reputation? What about assessing – and trying to remedy – all the intangibles associated with product and performance concerns?

Have you received notification of non-compliance? CRx Can Help