Who We Are

With strong and solid industry expertise, A Wright Path® navigates and executes the FDA and global regulatory requirements and submissions so our clients can achieve the launch of their products with confidence into the marketplace. We offer strategy and quality solutions in the following industries:

 

Medical Devices
Dental Laboratories
Consumer Product Industries, including Cosmetics
Combination Products

How We Help

We see your product through its entire life cycle. From strategy and regulatory submissions through post market surveillance, A Wright Path® is with you every step of the way.

A Wright Path areas of expertise

Learn how to get on the Wright Path!

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What We Offer

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

We offer the Right Path, Right Now® to develop, implement and sustain your Quality Management System for compliance to global regulatory requirements.

DESIGN AND DEVELOPMENT

We offer the Right Path, Right Now® to define global regulatory and customer requirements to ensure compliant products and patient safety.

AUDITING / TRAINING

We offer the Right Path, Right Now® to prepare your organization for the global marketplace today and the future.

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See how we’ve brought our Partners Success

With strong and solid industry expertise, A Wright Path® navigates and executes the FDA & global regulatory requirements from design to approval so our clients can achieve the launch of their products with confidence into the marketplace.

Meet Our Path Leaders

Meet some of our Consultants

Latest News and Events

FDA announces final guidance and upcoming webinar on Medical Device Reporting for Manufacturers

Today, the FDA issued final guidance on Medical Device Reporting for Manufacturers.  This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical […]

CDRH Industry: The FDA Launches New Webpage for Reporting Allegations of Regulatory Misconduct

Today the FDA launched a webpage on Allegations of Regulatory Misconduct, which are claims that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. The website explains the process for submitting allegations to the Center for Devices and Radiological Health (CDRH) and contains a form to […]

CDRH Industry: FDA Updates Expedited Access Pathway (EAP) Program website

Today, the U.S. Food and Drug Administration updated the Expedited Access Pathway Program website with two Data Development Plan examples that serve as a resource for sponsors. In April 2015, the FDA issued the Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions […]

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402 Lytham Court Suite 101 Moon Township, PA 15108
844-297-7284

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Contact us today to Partner with A Wright Path®, we are ready to get you on the Right Regulatory Path, Right Now!