FDA Approvals Accelerated for Medical Device Company

Challenge

To accelerate their approvals process and keep up with client timelines, the medical device company onboarded a top Axiom lawyer over a single weekend to support an initial pod of 5 new customers. The attorney, formerly an FDA Practice Lead at an AmLaw 100 firm, takes charge of coordinating and preparing regulatory submissions to the FDA and other international regulatory bodies. She also reviews informed consent forms (ICFs) for clinical studies and drafts service & collaboration agreements with new customers.

Approach

To accelerate their approvals process and keep up with client timelines, the medical device company onboarded a top Axiom lawyer over a single weekend to support an initial pod of 5 new customers. The attorney, formerly an FDA Practice Lead at an AmLaw 100 firm, takes charge of coordinating and preparing regulatory submissions to the FDA and other international regulatory bodies. She also reviews informed consent forms (ICFs) for clinical studies and drafts service & collaboration agreements with new customers.

Impact 

• Engaged with FDA representatives to secure product compliance by updating product labeling, marketing literature, and clinical protocols.
• Secured the earliest possible approval for new diagnostic products to align with the business’ demanding sales and marketing timelines.
• Enabled the client’s customers to start their clinical trials without delay, speeding up their ultimate go-to-market time.