Comprehensive Solutions for Regulatory Strategy & Submissions

Navigating the regulatory landscape while preparing products for market can be confusing, but the ECI team is ready to help. Our comprehensive solutions are designed to streamline the regulatory process, ensuring your products meet compliance standards efficiently.

The ECI Approach

When our clients need support with regulatory strategy, our team employs into an intentional process and plan to clearly define a plan to meet your specific needs.

Regulatory Intelligence

Our experienced regulatory experts make it a priority to stay current on global requirements in the rapidly-changing regulatory environment. We also provide a forum for our consultants to share their knowledge and facilitate collaboration while providing practical solutions for our clients.

Regulatory Strategy Development

First we craft a robust proposal. Our experienced team collaborates with you to develop an approach tailored to your specific requirements, taking into account the unique aspects of your product and any applicable regional variations.

Pre-Submission Consultation

Our pre-submission consultations are designed to help mitigate potential risks. Lean on our expertise in interacting with regulatory authorities, and ensure that potential issues are identified and addressed before the submission process begins.

Quality Management System (QMS) Optimization

ECI can help enhance your Quality Management System to better meet regulatory standards. We’ll assist in optimizing your QMS, ensuring it aligns seamlessly with regulatory requirements for the life sciences industry.

Gap Analysis and Remediation

Our experts will identify gaps in your regulatory processes and help implement effective remediation strategies. We’ll conduct thorough gap analyses and provide practical solutions to address any shortcomings we uncover.

Global Regulatory Submissions

We’ll help you efficiently navigate diverse regulatory requirements anywhere in the world. Our team specializes in preparing and submitting regulatory documents for the life sciences industry, facilitating approvals and market access across different regions.

The Benefits of ECI Solutions

Strategic Guidance

Our consulting services are always tailored to your specific products and markets, ensuring a proactive and custom approach to regulatory compliance.


When you streamline the submission process with our efficient and organized approach, you also reduce time-to-market while staying competitive.

Risk Mitigation

Our experts will identify and mitigate potential regulatory risks early on, minimizing delays and setbacks and maximizing production.

Comprehensive Support

From strategy development to submission and post-approval activities, we provide end-to-end support so you can meet your regulatory goals.

Impact That’s Tangible

Why not see for yourself the value ECI provides to clients through technology transfer? Find insight on how we support customers through case studies specific to technology transfer.


Post Market Surveillance & Vigilance Case Study


Post Market Surveillance & Vigilance Case Study


Post Market Surveillance & Vigilance Case Study


Technology Transfer Case Study


Technology Transfer Case Study


Technology Transfer Case Study


Our Strategic Services

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.

See All Services

Get Started Today

Proactively addressing regulatory requirements comes with a peace of mind that’s invaluable. Our team at ECI is ready to help you tackle your regulatory challenges head-on while improving your internal processes along the way. Contact our expert team to discuss requirements as they relate to your specific work, and see for yourself how our solutions can simplify the path to regulatory compliance for your organization.

Contact US