Why ECI?

Why Your Business Would Benefit from a Consultation

  • Are you preparing for an upcoming audit?
  • Have you had an audit from a regulatory agency and want a deeper review of your processes and/or documentation?
  • Do you want an independent review of systems to stay ahead of regulatory challenges and costly penalties?
  • Do you want to identify potential risks in manufacturing processes to prevent expensive recalls or product failures?
  • Do you lack internal resources to audit processes yourself?
  • Did you receive an FDA warning letter or an FDA 483 letter?

Don’t delay! 

Without a clear plan to effectively address citations and proper remediation activities, your customers, regulators, and investors may question your business’s credibility. You are also at risk of further enforcement actions, including significant fines, product seizures, injunctions, and criminal charges if they are not resolved.

Get ahead and stay ahead.

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Services

Types of Audits to Safeguard Your Business

We offer services designed to ensure your operations meet the highest standards and are fully prepared for any inspection. Our global audit services include, but are not limited to:

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Internal

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Supplier

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QMS Gap Assessments

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ISO 13485

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21 CFR 820

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ISO 9001

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MDSAP Audit

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EU MDR

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EU IVDR

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GMP Audit 

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GxP Audit 

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Mock FDA Inspection 

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M&A Due Diligence

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Our Process

A Step-by-Step Approach to Ensuring Compliance, Quality, and Corrective Remediation

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Pre-Audit Preparation 

Our team works with you to gather necessary documentation, review procedures, and ensure your organization is ready for a thorough audit or inspection.

Execution of Mock Audits/Inspection 

We conduct a detailed mock audit or inspection, simulating real regulatory conditions to identify gaps in compliance and operational processes.

Generate Audit Report

After the audit, we provide a comprehensive report outlining our findings, including any non-conformances or areas for improvement.

Generate Corrective Action Plans 

We collaborate with your team to develop corrective action plans that address the identified issues and improve overall compliance.

Post-Audit/Remediation Support

​​Our experts continue to support you through the remediation process, ensuring all corrective actions are implemented effectively and fully compliant with all laws and regulations.

Benefits

Your Trusted Partner in Life Sciences Compliance and Quality

Audit experience and capabilities across numerous GxP areas.
Flexible approach.
Global auditors with diverse language skills.
Auditors with FDA and regulatory agency experience.
Comprehensive pricing model.
Speed of Implementation.
Knowledge transfer.
Focus on core competencies.
Testimonials

"I am pleased to wholeheartedly recommend ECI consultants for their outstanding collaboration during our quality system implementation and remediation, audit preparation and readiness, as well as their pivotal role in our multi-site support endeavors across both the US and Europe. Their comprehensive regulatory knowledge, strategic insights, and meticulous audit groundwork have been integral to our achievement of compliance and enhanced credibility."

Sr. Manager, Global Quality Systems

"I give my full endorsement to the key attributes that ECI will bring to your organization. Specifically, their knowledge, professionalism, drive, quality of work and eagerness to do things right the first time will add value to your impending project needs. Brijesh and Shital were the project lead on multiple devices ranging from urology to endoscopy; all work has passed multiple audits in the years since."

Sr. Process Development Engineer

"ECI was contracted to support a large remediation project. Thanks to Randy providing onsite project management, the additional quality system resources needed to address the issues were quickly defined. ECI was able to deploy many highly qualified consultants as requested. The entire ECI team was professional, collaborative, and hard-working. The regulatory resources provided positive contributions on day one, given their valuable skillsets such as software development, engineering experience and a former FDA reviewer."

Sr. Director of Regulatory Affairs

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