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KNOW YOU'RE ON THE RIGHT REGULATORY PATH RIGHT NOW
We are a trusted name in regulatory strategy, navigating your path to FDA and worldwide compliance.
KNOW YOU'RE ON THE RIGHT REGULATORY PATH RIGHT NOW
We are a trusted name in regulatory strategy, navigating your path to FDA and worldwide compliance.
The Right Intelligence
We gather the right regulatory information to incorporate into an executable regulatory strategy.
The Right Experience
The A Wright Path team is comprised of highly seasoned professionals with industry experience.
The Right Strategy
We define the regulatory strategy that achieves results and milestones to commercialization.
The Right Path
With the Right Intelligence, Right Experience, Right Strategy, you know you’re on the Right Path, Right Now®
What we do
With strong and solid industry expertise, A Wright Path® navigates and executes the FDA & global regulatory requirements from design to commercialization, enabling our clients to confidently launch and maintain their products into the marketplace.
Regulatory Affairs
We offer the Right Path, Right Now® to expedite your products faster to the global marketplace with maximum regulatory efficiency to avoid regulatory hurdles.
Quality Management System (QMS)
We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.
Design Quality Assurance
We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.
Quality Assurance
We offer the Right Path, Right Now® to ensure all the planned and systematic activities are implemented within the quality management system to provide confidence in a quality product or service.
Post Market Surveillance (PMS)
We offer the Right Path, Right Now® to ensure a collection of processes and activities to monitor the performance of a product.
Remediation Activities
We offer the Right Path, Right Now® to ensure a quality plan to define remediation activities, root causes, and corrective actions as well as risk during remediation activity.
Continuous Improvement
We offer the Right Path, Right Now® to reduce waste, increase efficiency, and improve internal employee and external customer satisfaction.
Safety
We offer the Right Path, Right Now® to develop and implement policies, ensuring that procedures are in place for the safety and health of employees within a workplace.
About us
We interface with regulatory agencies on your behalf while acting as your strategic partner
With strong and solid industry expertise, A Wright Path® navigates and executes the FDA and global regulatory requirements and submissions so our clients achieve the launch of their products with confidence into the marketplace. We offer right path solutions in the following industries:
- Medical Devices
- Dental Laboratories
- Combination Products (Device, Drug, Biologic)
- Consumer Product Industries (including Cosmetics and Children’s Products)
Success Stories
Here are just a few examples of how we led our clients on the path to success!
A WRIGHT PATH GUIDES MANUFACTURERS IN 510(k) CLEARANCE OF SEQUENTIAL ALIGNERS
A Wright Path’s team recently guided several dental labs in successfully achieving 510(k) clearance for their sequential aligners…
SURGICAL DEVICE MANUFACTURER’S PATH LEADS TO MARKETING THEIR PRODUCT SAFELY IN THE US
A Wright Path® was approached by a small medical device manufacturer searching for quality and regulatory support to not only function…
A WRIGHT PATH RESCUES COMPANY AFTER PREVIOUS CONSULTANTS FAIL
A medical device implant company approached A Wright Path® after other advisors failed to implement a quality solution…
How we help
We guide your product through its entire life cycle and everything in between
From design, regulatory strategy and submissions through post-marketing surveillance, A Wright Path® is with you every step of the way.
News & Events
A Wright Path® is a trusted name in global regulatory compliance and strategy, navigating your path to FDA and worldwide regulations compliance.
Advice from Experts on Getting Your Start Up Medical Device...
As a new medical device start up, the process of…
FDA announces final guidance and upcoming webinar on Medical Device...
Today, the FDA issued final guidance on Medical Device Reporting for…
CDRH Industry: The FDA Launches New Webpage for Reporting Allegations...
Today the FDA launched a webpage on Allegations of Regulatory Misconduct,…
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