Pathmaker FDA Law

Pathmaker FDA Law is a specialized regulatory law firm founded in 2017 by Amy Fowler, focusing exclusively on FDA compliance for medical device and pharmaceutical manufacturers and distributors. The firm provides legal counsel and regulatory strategy development for companies navigating domestic and international regulatory pathways.

The firm has served nearly 100 clients over seven years, leveraging founder Amy Fowler's 30+ years of regulatory affairs experience across devices, pharmaceuticals, and tissue products. Pathmaker's approach combines legal expertise with hands-on industry experience, having worked in both large multinational corporations and boutique consulting environments. The firm handles regulatory submissions, compliance strategy, and market access planning for FDA-regulated products.

Amy Fowler holds both RAC certification and FRAPS designation from the Regulatory Affairs Professionals Society, and serves as an adjunct graduate professor teaching regulatory courses. This combination of legal practice, industry experience, and academic involvement positions the firm to serve innovators and entrepreneurs navigating complex global regulatory requirements.

Choose Pathmaker FDA Law when you need specialized regulatory legal counsel that combines industry experience with legal expertise. The firm is particularly valuable for companies facing complex FDA submission challenges or developing multi-market regulatory strategies.

Expect a consultative approach informed by decades of hands-on regulatory affairs work. The firm's exclusive focus on FDA-regulated businesses means they understand both the regulatory requirements and the business realities manufacturers face when bringing products to market.

Pathmaker FDA Law serves exclusively within the healthcare sector, focusing on businesses regulated by the FDA and comparable international agencies. Their practice centers specifically on medical devices and pharmaceuticals, addressing the unique regulatory compliance challenges these industries face.

The firm's healthcare specialization extends to understanding the commercial pressures and innovation cycles specific to medical technology and pharmaceutical development, informing regulatory strategies that align with business objectives while maintaining compliance with FDA requirements.

Medical device and pharmaceutical manufacturers at any stage from development through commercialization who need strategic regulatory legal guidance. Companies preparing complex FDA submissions, navigating international regulatory pathways, or requiring regulatory due diligence for business transactions will find particular value.