Regulatory Compliance Services

Receiving notice of enforcement actions from a regulatory body can be a challenging experience. Understanding extensive regulation changes introduced under the EU MDR (2017/745 and IVDR 2017/746) can also be overwhelming. With ECI compliance experts by your side, we can assess your specific needs to define an appropriate solution. Partner with ECI to plan for and maintain compliance in your day-to-day operations.

By the Numbers

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ECI experts understand that sometimes large-scale regulatory compliance efforts overwhelm internal teams for a wide variety of reasons. When you partner with ECI, we help correct any compliance issues while helping to bolster and refine your internal processes along the way. Our highly strategic remediation services, regulatory compliance strategies, and pre- and post-market support tactics allow our clients to return their projects back on track quickly and effectively.

Contact ECI to receive assistance from qualified professionals if you’ve received an FDA warning letter, 483 Observations, or notified body observation.

Let's Collaborate

Our Capabilities

Regulatory Compliance

  • Current Good Manufacturing Practices (cGMP) Compliance
  • EU MDR & EU IVDR Transition Support
  • Regulatory Strategy
  • Remediation – Form 483, Warning Letter, Consent Decree, Notified Body Observations
    • Project Management
    • Gap Assessment
    • Agency Response
    • Remediation Strategy & Execution
  • Modernization of Cosmetic Regulation Act (MoCRA) Compliance

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients in need of regulatory compliance services? Find insight into the types of challenges our clients have faced through case studies.

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Regulatory Case Study

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Our Strategic Services

Looking for support outside of regulatory compliance? Our team is here to expertly guide you through every product lifecycle challenge you may encounter. Learn more about our other service offerings through the link below.

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Let Us Help

You focus on your business. We focus on the momentum of the industry and help you keep pace across your portfolio.

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