Areas of expertise

Submissions

We have years of experience and a successful track record of submitting 510(k)'s to the FDA & CE Mark documentation to the EU.

Clinical Trials

Many times it is necessary to perform human clinical trials, or studies, to obtain approval to legally market a product.

Quality Services

We create and ensure you have a formal quality system in place for designing and producing products for market.

Who we are

Regulatory Specialists, Inc. is a team of skilled FDA and International medical regulatory consultants in the Medical Device, Diagnostic, and Pharmaceutical fields. Started in 1989 by Greg Holland, we help assure your compliance with FDA, ISO, and international requirements. Due to our skilled experience, Regulatory Specialists, Inc. will bring you the highest quality and innovative work possible at a most economical price.