ACHIEVING REGULATORY APPROVAL FOR A WOUND CARE PRODUCTS
The Challenge
A leading wound care company faced regulatory hurdles after their submission to the Notified Body received multiple queries. They required a revised clinical strategy, writing, and submission plan, to secure EU MDR approval without delays.
Our Approach
Developed new systematic literature review and safety reports
Designed protocols for two clinical studies to strengthen safety data
Executed a meta-synthesis to support an at-risk indication
Created a suite of revised documentation and supported submission to the Notified Body.
The Outcome
Approval Secured: Achieved full compliance ahead of schedule and within budget.
Expanded Partnership: The client extended their engagement to cover their entire product portfolio.
Client Testimonial
"Working with ECNE Research has been an absolute game-changer. The team not only provided clear and effective guidance on navigating the complex regulatory landscape but also managed our clinical documentation with precision and attention to detail. Their deep expertise and proactive approach made our regulatory process seamless. We highly recommend their services."
Director of Quality Assurance and Regulatory Affairs
SECURING APPROVAL FOR AN IMPLANTABLE CARDIAC DEVICE
The Challenge
A medtech company developing a novel cardiac implantable device engaged ECNE to support the preparation of the CER and related documents, in support of obtaining EU MDR approval.
Our Approach
Reworked Clinical Evaluation Report & Post Market Safety Update Report
Provided tried-and-tested templates to improve approval odds
Partnered closely with the client to fine-tune regulatory strategy.
The Outcome
Submission Success: Approval granted on the first regulatory submission with ECNE
Ongoing Engagement: Client retained ECNE for annual clinical updates.
STRENGTHENING VALUE PROPOSITIONS WITH DATA-DRIVEN DOSSIERS
The Challenge
A global radiotherapy company struggled to finalize high-impact value dossiers to support market access.
Our Approach
Revised dossiers with compelling clinical and economic narratives
Implemented a citation management system, ensuring streamlined referencing and enhanced data credibility.
Provided training for internal teams to enhance future submissions.
The Outcome
Dossiers Completed: on time and within budget
Enhanced Market Positioning: with stronger clinical-economic evidence
Client Testimonial
“Timely, efficient, and professional. ECNE transformed our value dossiers, making them investor- and regulator-ready.”
-Director of Health Economics and Public Affairs
GLOBAL REGULATORY STRATEGY FOR A NOVEL SENSORY DEVICE
The Challenge
A start-up developing a self-powered implantable device required a global regulatory strategy for market entry.
Our Approach
Conducted a deep analysis of regulatory landscapes in the EU and USA
Provided a roadmap for clinical trials, preclinical testing, and submission requirements
Identified accelerated approval pathways.
The Outcome:
Regulatory Strategy Delivered ahead of schedule
The client retained ECNE for full regulatory execution.
Client Testimonial
“Professional, efficient, and strategic. ECNE delivered exactly what we needed! I will continue working with ECNE!”
Chief Executive Officer
DESIGN & EXECUTION OF CLINICAL STUDIES
The Challenge
A global pharma packaging company required a post-market clinical study expansion into the USA. They needed to comply with regulatory expectations while generating new clinical data for future product development.
Our Approach
Secured IRB approval, recruited participants, and collected/analyzed data
Added new data points that supported the design of a next-generation product.
The Outcome
Study completed ahead of schedule, ensuring regulatory timelines were met
Data leveraged for regulatory & product development, enabling faster market expansion.
Client Testimonial
While formal client feedback is forthcoming, ECNE’s expertise in study design and execution ensured seamless regulatory compliance and successful outcomes. This study enabled the client to generate critical data for regulatory approvals and product development, reinforcing ECNE's ability to deliver high-impact, compliant clinical research solutions.
LITERATURE REVIEWS FOR RISK ASSESSMENT & COMPLIANCE
The Challenge
A medical technology company requires a rapid literature review to support risk assessment and regulatory compliance. They faced tight deadlines and needed highly structured, defensible findings.
Our Approach
Developed a comprehensive search strategy to identify risks and safety concerns
Engaged in planning meetings to ensure alignment with regulatory expectations
The Outcome
Delivered ahead of tight deadlines, allowing the client to stay on track for submission
Exceeded industry standards for literature reviews, strengthening the regulatory package.
Client Testimonial
“We are incredibly grateful for the expertise and guidance provided by ECNE Research in conducting our literature review. Their deep knowledge, meticulous approach, and collaborative spirit were invaluable in helping us navigate the research process. Their support ensured a comprehensive and well-structured review. We highly recommend ECNE to anyone seeking expert assistance in medical research.”
Senior Regulatory Affairs Manager
CLINICAL & MEDICAL AFFAIRS PARTNERSHIP FOR A VASCULAR DEVICE
The Challenge
A vascular technology company needed ongoing support for clinical studies, regulatory compliance, and scientific publications.
Our Approach
• Designed and executed five post-marketing clinical studies
• Engaged Key Opinion Leaders (KOLs) for expert insights
• Provided regulatory documentation and medical affairs support
The Outcome
Client integrated ECNE as an extension of their internal team
Client Testimonial
"The ECNE team has been an invaluable partner in ensuring regulatory, clinical, and medical affairs success. Their expertise and strategic guidance have been instrumental in advancing our clinical studies and facilitating impactful scientific publications."
Chief Medical Officer
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