With regulatory expertise in global markets, we bring clarity and direction to your process.

Delivering a medical product to market can be a long and complicated process, even when you’re familiar with the regulatory requirements.

But when requirements are rapidly changing or when you’re entering international markets, the process can seem insurmountable.

Regulatory Consulting

At NAMSA, we provide efficient, responsive regulatory and quality services across the full spectrum of product design and development— and we stay with you for post-market support as well. From high-level expertise to practical working solutions, our staff develops and implements global regulatory strategies.

FDA Consulting

We also prepare submissions, plan testing, and manage communications with regulatory bodies. With our approach, you maintain project control while gaining the benefit of on-demand external support—whether it’s to extend your in-house capabilities or get access to the specialized expertise you need.