Scienonyn – Regulatory Submissions and Drug Safety Surveillance Experts

Your Partners in Success

As your trusted partner, ECI provides strategic consulting and service solutions for the life sciences industry. Lean on our diverse perspectives and decades of experience to tackle your toughest challenges within your dynamic field.

Proven Solutions for Your Regulatory, Quality & Engineering Needs

At ECI, our expert team has assisted a broad range of companies solve an even broader range of challenges, from full product lifecycle management, regulatory strategy, and post market surveillance to successful remediation and beyond. We’re here to help you identify pain points in your processes and meet them with effective solutions as we chart the best path forward together.

97%

Client retention rate

285 Projects managed within the last three years

100+

Consultants ready to support each project

Industries We Serve

We understand the complexity and ever-changing nature of the regulatory landscape. Our consultants possess the in-depth expertise required to navigate the distinct compliance requirements within various industry sectors under the life sciences domain. This ensures that, even when challenges arise, you can proceed with unwavering confidence.

Clients We Serve

Our Strategic Solutions

FDA Warning Letter

EU MDR

IVDR

Regulation Strategy & Submissions

Technology Transfer

Post Market & Resources Management

Merger & Acquisitions and Due Diligence & Integration

Impact That’s Tangible

Why not experience the value ECI delivers to a myriad of clients firsthand? Explore our collection of case studies to gain insights into the challenges our customers have encountered. Delve into project objectives, actions, strategies employed, and the resulting outcomes for each.

EU MDR Regulatory Submissions

Regulatory Strategy

Warning Letter: Regulatory Responsibility

When You Succeed, We Succeed.

The quality of the work we do builds trust and sets the stage for long-term, effective relationships. See what ECI customers are saying about working 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. "

"I cannot say enough great things about the ECI consultants. They are doing absolutely great work and adding a ton of value!"

"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."

"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."

Our People

Relationships matter, and when you choose to do business with a corporation, you’re choosing to do business with the people who make it up. Our team at ECI promises to work hard to help our clients achieve compliance for their products, but more than that, to build lasting relationships through mutual respect and trust. Join the Team.

Let’s Collaborate

Whether you have an issue that requires immediate response or you’re looking for a partner equipped to help improve your processes long-term, let us help you address your market challenges. We would welcome the opportunity to support you.