Regulatory | Pre-Market
There are a lot of regulatory consultancies out there to help develop a regulatory strategy and execute a submission, but what about having engineering and quality considerations factored in during the process. Last year EdgeOne Medical clients saved 30% by using our cross-functional supported regulatory services.
More than just Strategy & Submission Services.
More than just Strategy & Submission Services.
What Makes Us Different
Knowledge & Resources
Resource Network
Cross-Functional Perspective
Based on our experience supporting dozens of product launches, we provide training and basic regulatory compliance education to help your organization understand regulatory basics and beyond, giving you more confidence in your business decisions.
We have a large network of trusted colleagues who are subject matter experts and thought leaders. They are resources which provide assurance when regulatory decisions and strategies involve unique products and technologies.
Understanding how data elements interrelate, how data changes throughout the development process, and piecing all that information together to support your regulatory profile is strengthened by our cross-functional experience.
Features
Regulatory Strategy and Planning
Strategies and Plans which are augmented with our cross-functional product development experience in concert with your business goals and capabilities.
Development Insights
Pragmatic, Risk-Based Options
Living Strategy
A strategy that doesn’t just define the path and activities to regulatory approval but also enhances your understanding of how they affect your product development efforts.
Sometimes your ideal product can't easily or cost-effectively be brought to market. By understanding your target product and business profile, we determine risk-based options to achieve desired business goals.
We save development costs and time by monitoring your strategy throughout product development, while considering changes in the regulatory environment and your development progress.
Submission Authoring
Regulatory submissions can contain extensive and diverse volumes of data, but they all have the same goal: demonstrating that your product is safe and effective. Authoring submissions requires telling a story, not just cutting and pasting data.
Comprehensive Approach
Time Sensitive
Submission Risk
Your submission should take into account all the data collected about your product. We can use our cross-functional expertise to help you make sure that the correlations between data accurately reflect your product’s characteristics.
It’s the 11th hour before submission and you just realized more time is needed to generate the last piece of data. We understand the development efforts for deliverables included in submissions, and help avoid surprises and delays.
Have an understanding of your chances for a successful submission before you submit. Don’t be surprised by unexpected deficiencies. Our pre-submission assessment identifies potential concerns that may arise during agency review.
Regulatory +
Because EdgeOne Medical can integrate your Product Development Services, you get more out of each component when they work together.
+ Project Management
+ Quality Systems
+ Testing
Get valuable insights on your timelines and better understand potential risk points.
Have more confidence developing your product within the guard rails of quality and regulatory.
Understand if your claims are being realized in the V&V stage of product development.
Questions?
Request a Consultation
Get Knowledge
Speak with a Product Development Specialist to learn more about our services.
Schedule a consultation with one of our experts about your specific needs.
Get answers and insights on the product development process from experts.
Call 1-312-300-6640
