Bringing a drug or product to market is a monumental achievement, but not one without extensive, long-term planning and execution. Life Law Partners can be a powerful ally with you during this process, ensuring at each step of the way that your legal and regulatory needs are met, interfacing with relevant agencies on your behalf along the way.
Life Law Partners can assist with your new drug application, providing legal and consulting support as your product advances through the approval process. We have particular experience with orphan-drug designations, providing special assistance to those companies providing valuable products to such niche fields and markets.
Life Law Partners can assist with the medical-device approval process, including the proper classification of your device and assistance in seeking the proper approval method, including premarket notifications, premarket applications or humanitarian device exemptions.