Pathmaker FDA Law specializes in medical device and pharmaceutical regulatory law.

We help manufacturers and distributors get their products to market and navigate through regulatory uncertainty.

NAVIGATING THROUGH REGULATORY UNCERTAINTY

For nearly 30 years, the attorneys of Pathmaker FDA Law have led medical device, pharmaceutical, and other highly regulated business through regulatory uncertainty. By developing and executing visionary regulatory strategies, they have guided hundreds of medical devices and drugs to market. 

FOCUSED ON SERVING YOUR BUSINESS NEEDS

Pathmaker FDA Law only focuses on businesses regulated by FDA or comparable international regulatory agencies.  

 

The firm primarily serves medical device and pharmaceutical companies looking to get their products to market.

PATHMAKER KNOWS YOUR CHALLENGES AND GOALS

We have experience working in the medical device industry before practicing law. We have personally experienced the challenges faced by the medical and pharmaceutical industries, and that experience sets Pathmaker FDA Law apart from other law firms.

Services

Medical Device Submissions

510(k) Submissions

PMA Submissions

De Novo Submissions

Drug Applications

New Drug Applications

FDA Milestone Meetings

Investigational New Drug Applications

Request for Designation

Is your product a device or a drug or both? We will help you determine what regulatory pathway you will need to follow.

Listing and Registration

Need to register a manufacturing facility with FDA? Pathmaker will guide you through the process of registering and listing where your product is made.

Pre-Submissions

We will help you prepare for meeting with FDA to obtain FDA feedback prior to submission.

General Guidance

Overwhelmed by the regulatory scheme you are facing? We know the challenge. We will guide you through what you need and how to get it.

Clinical

Need help developing your clinical trials and evaluation plan? We’re here to help.

Compliance

 

All Services

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PUT PATHMAKER’S EXPERTISE TO WORK FOR YOUR BUSINESS.

Contact Us To Talk About Your Next Regulatory Challenge.