TAKE THE RIGHT PATH, RIGHT NOW®, WITH EXPERT FDA COMPLIANCE CONSULTANTS

We’re your FDA interpreter! As a trusted FDA compliance consultant, we can help navigate your path to FDA compliance — and more!

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 introduce 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 gets your product to market.

The Right Path

With the Right Intelligence, Right Experience and Right Strategy, you know you’re on the Right Path, Right Now®.

What we do

As industry experts, A Wright Path® navigates and executes FDA (Food and Drug Administration) & global regulatory requirements from design to commercialization. We enable our clients to confidently launch and maintain their products in the marketplace. Learn how you can take the Right Path, Right Now®.

Regulatory Affairs

Expedite your product development and hit the global marketplace with maximum regulatory compliance in FDA Regulatory Submissions, CE Marking and more — while avoiding hurdles.

Quality Management System (QMS)

Develop, implement and sustain your Quality Management System for compliance with global regulatory requirements, including FDA regulations, ISO standards and Good Manufacturing Practices (GMP).

Design Quality Assurance

Define global regulatory and customer requirements to ensure compliant products, design validation and patient safety.

Quality Assurance

Maintain your quality management system with an internal audit plan and other strategies. Provide confidence in a quality product or service by conducting a mock FDA inspection or ISO Audit.

Post Market Surveillance (PMS)

Conduct processes and activities to monitor (and improve) the performance of a product.

Remediation Activities

Implement a plan to define remediation activities, determine risk, discover root cause and design corrective actions following warning letters, audits (internal, FDA or regulatory bodies) or gap assessments.

CLINICAL TRIAL & STRATEGY

Expedite your product development and hit the global marketplace with maximum regulatory compliance in Clinical Trial Strategy, Clinical Trial Monitoring, Clinical Trial Regulatory Submissions, and more.

About us

We interface with regulatory agencies on your behalf as your strategic partner. With industry expertise, A Wright Path® navigates and executes FDA and other global regulatory submissions so you can launch your product with confidence. We offer solutions in the following industries:

Success Stories

See how we’ve led our clients on the Wright Path to success!

A WRIGHT PATH GUIDES MANUFACTURERS IN 510(K) CLEARANCE

A Wright Path’s team recently guided several dental labs in successfully achieving 510(k) clearance for their sequential aligners after they received several non-conformances in a customer audit.

SURGICAL DEVICE MANUFACTURER MARKETS WITHIN THE US THANKS TO A WRIGHT PATH

A Wright Path worked with the company to implement a new quality management system and continues to provide daily quality and regulatory functions, including project management, internal audits and non-conforming product control.

A WRIGHT PATH RESCUES COMPANY AFTER PREVIOUS CONSULTANTS FAIL

After other advisors failed, A Wright Path consultants developed a successful strategy and implemented a Quality System in under three months.

How we help

We guide your global and FDA-regulated product from pre-submission to post-production — 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. Call today to get on the “Wright Path” with a trusted FDA compliance consultant.