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.
Practice Areas
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.
Registration and Listing
Need to register a manufacturing facility with FDA or list your devices? 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
Need advice on how to stay in FDA’s good graces or develop a quality system? We can help you keep your products on the market by being compliant.
All Services
Not seeing what you’re looking for? Check out all our legal services here.
PUT PATHMAKER’S EXPERTISE TO WORK FOR YOUR BUSINESS.
Contact Us To Talk About Your Next Regulatory Challenge.
