Services

Pathmaker FDA Law has nearly 30 years of experience in guiding medical device and pharmaceutical businesses in getting their products approved or cleared. We understand what regulatory bodies require and what path is right for you to get your drug or device to market. 

Contact us to guide your business to “yes”.

Medical Devices

510(k) Submissions

We’ll guide you through the process and help craft the 510(k) submission to ensure that it meets the substantial equivalence criteria and is approved on its first submission.

PMA Submissions

Our team will help you put together your pre-market approval to demonstrate that your device is safe and effective.

De Novo Submissions

No predicate device? We’ll help guide you through the process when this is the case to get your device to market.

MDD and MDR

Need help making your device MDR compliant? We can help create your plan to gather clinical data to continue to market in Europe.

513(g)s

Not sure what class your device falls into? Pathmaker will help craft your device description.

International Medical Device Submissions

 

Investigational Device Exemptions

 

Pharmaceuticals

New Drug Applications

Submitting a New Drug Application? Pathmaker will assist you in crafting your application to demonstrate its safety and effectiveness.

Investigational New Drug Applications

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

Drug type A, B, and C Meetings

Need help preparing for a meeting with FDA? Let us help you prepare what you will need to get your drug to market faster.

505(b)(2) Pathway

Orphan Drugs

Other Services

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.

Pre-Submissions

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

Pre-Submission Meetings

The team at Pathmaker will go with you to meet FDA to obtain their feedback prior to a submission.

FDA Milestone Meetings

Preparing for meeting with FDA for your drug or device? We will provide the information and strategy you need to prepare.

Registration and Listing

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

General Guidance

We’ll guide you through the process and help craft the 510(k) submission to ensure that it meets the substantial equivalence criteria and is approved on its first submission.

Clinical

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

Compliance

 

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