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Regulatory, Quality and Engineering Consulting Services

CRx Life Sciences brings a wealth of strategies, best practices, experience, knowledge, tools, and methods that will withstand regulatory scrutiny and improve product quality.

To simplify the process of meeting FDA and global compliance regulation requirements, we break down our compliance services into categories. It takes experience and critical knowledge of every step of the process to bring a product to market while navigating through the complex regulatory compliance requirements.

At CRx we offer a range of flexible and comprehensive services to the pharmaceutical, biomedical technology, medical devices and related industries. Our services assure our clients’ products follow FDA or global government standards and meet regulations, along with ensuring quality, efficacy and safety in bringing to market innovative life-changing – even life-saving – advancements in the life sciences field.

Our focus is on assisting clients in establishing compliance protocols for products in development, improving existing operations and facilities to stay compliant in a rapidly changing environment, and aiding with the successful resolution and remediation of quality and compliance issues.

Learn more about our Regulatory, Quality and Engineering Consulting Services:

Manufacturing
Our product-manufacturing specialists provide consulting services and resources to help bring your product into full production. MORE
Validation
Performed at appropriate points along the project timeline, validation ensures compliance and maintains time-to-market objectives. MORE
Regulatory Compliance
With proven experience, we gain compliance for our clients’ products under challenging conditions and aggressive deadlines. MORE
Program Management
Our team of industry experts has the know-how and tools to manage your compliance initiatives from concept through final approval. MORE
Non-Compliance Remediation
From startups to remediation of 483s, warning letters and consent decrees, CRx has the expertise to help your company remain FDA compliant. MORE
Research & Development
Early involvement can optimize the compliance process, improve product quality and help accelerate time to market. MORE
Technical Services
Oversight, engineering and software services throughout medical devices, pharmaceutical and biotech product development. MORE

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