Our Strategic Solutions

We offer our clients diverse perspectives, proven experience, and vital confidence in the face of the most daunting challenges. Learn more about a variety of trusted solutions we’ve developed over time that successfully address a wide range of compliance needs.


We've seen it. We've solved it.

Whether you’ve received a letter of non-compliance or you need support getting your next product market-ready, our experienced team is poised to step in right when you need us most.

Some of our most sought-after solutions include:

Strategic Consulting Services for the Life Sciences

Simply put, ECI exists to ensure the life sciences keep pace with human need. Our mission is to expertly guide you through every product lifecycle challenge you may encounter, shoring up your processes and the quality of your products along the way.

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Your Industry, ECI’s Solutions.

We understand the nuances of your complex and evolving market, and we’re committed to helping you navigate quality management and compliance regulations as they apply to the important work you do.

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Industry News

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Case Studies

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Our Expertise Supports Your Compliance.

Turnkey Solutions

We offer customized support for your compliance programs.

Decades of Experience

We’ve seen it and we’ve solved it.

Parallel Fast Tracking

Our work doesn’t have to happen sequentially. Instead, we identify and anticipate needs to mitigate delays.

Work With Us

When You Succeed, We Succeed.

The quality of our work establishes trust and paves the way for enduring, productive partnerships. Discover what ECI customers have to say about their experiences with us.

"What an amazing accomplishment! Thank you to the team and all who supported this effort! To pull this in as far as you did is outstanding! This will ensure submission of the product early next year and finish the last submission. Awesome job everyone. "
Project Manager
"I cannot say enough great things about the ECI consultants. They are doing absolutely great work and adding a ton of value!"
Director, Global Product Marketing
"I would like to thank you all for being the leaders this program needs, exhibiting many elements of the company’s recognized 4 pillars of Leadership: Strategic, Collaborative, People, Performance."
R&D Manager
"This submission will ensure the product remains available to our patients for years to come. The team displayed continuous cross-functional collaboration, adaptability, and constant focus to achieve an on-time submission. Thank you to each team member for your hard work, and countless hours of dedication to achieve this great goal of submitting for EUMDR approval."
R&D Project Manager
“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
"This is a moment to reflect and thank you for your contribution to our integration’s core system and distribution 'go live' project and for the extra effort you put in day in and day out to ensure a smooth transition. Your creativity and willingness to collaborate continuously set a high bar within the project team.”
Sr. Technical Writer
"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 has helped our company create key quality system policies and procedures. The ECI management is very collaborative, engaging, and responsive to our needs. They ensured that the work was managed effectively and efficiently."
VP of Corporate Quality
"Based on their experience, ECI recommended placing on-site managers to assist with activities and personnel, which eased the added strain on our full-time managers due to the number of contracted resources. I would not hesitate to use ECI for future projects; I found their professionalism and depth of resources was second to none. We succeeded in completing our mission and owe a great deal of the success to Enhanced Compliance."
Director, Engineering & Product Development
“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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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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