Strategic Consulting Services for the Life Sciences Field

Simply put, ECI exists to ensure the life sciences industry keeps pace with the changing needs of humanity. Our mission is to expertly guide you through every product lifecycle challenge you may encounter, fortifying your processes and the quality of your products along the way.

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Our team is fully equipped to help you navigate the complex and ever-changing regulatory compliance requirements as they apply to the critical work you do. Lean on our proven strategies, experience, and specific industry knowledge to address issues of quality or compliance and bring your next product to market more efficiently than ever. Our comprehensive services help ensure your products follow FDA or global government standards and meet necessary regulations, while also guaranteeing quality, efficacy and safety in these innovative, life-changing, and sometimes even life-saving advancements in the life sciences field.

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Manufacturing Engineering

Services

Project Management
Research & Development
Technical Services
Mergers & Acquisitions Support
Post Market Surveillance & Vigilance
Regulatory
Risk Management
Quality
Project Management
Research & Development
Manufacturing Engineering
Quality
Risk Management
Regulatory Affairs
Regulatory Compliance
Post Market Surveillance & Vigilance
Mergers & Acquisitions Support
Technical Services

Our Reliable Solutions

ECI provides clients with diverse perspectives, a track record of proven experience, and vital confidence in the face of daunting challenges. Learn more about our trusted solutions developed to address a variety of compliance needs.

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Why ECI?

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

Our multidisciplinary team has helped a broad range of clients successfully address an even broader range of challenges, from resource management to quality control to successful remediation and beyond. We embed as a laser-focused, managed resource to help our clients navigate acute challenges they aren’t well-equipped to tackle on their own. Our process also means your operations can continue in parallel to the services we provide your team. Ready to get started?

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Who We Serve

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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+1-855-324-6279 (US)+506-4052-5450 (Latin America - Costa Rica)
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