Our Company

Let us help you get your product to market!

Regulatory Specialists, Inc. has been helping companies like yours get their medical device, diagnostic, biologic and pharmaceutical products to market for more than 20 years. We can take your product into any worldwide market and assist you from concept through post-marketing surveillance and beyond.

One-on-one regulatory assistance

Our firm was started by Greg Holland, a former pharmaceutical/device firm executive, in 1989. Our first five projects came from Greg’s former employer. Since then, we have been providing one-on-one regulatory assistance to a variety of companies, from tongue depressors to mechanical heart implants and everything in between.

A variety of specialties

We also have many consultants that work with us, and we add more every year. Our group of consultants includes notified body auditors as well as ex-FDA employees. Our team can handle every project for any type of product, as we employ consultants with a wide variety of expertise.

Our consultants include:
  • Statistical specialists
  • Software specialists
  • Clinical specialists
  • FDA submission specialists
  • CE Mark specialists
  • ISO 13485 specialists
  • International specialists
  • And many others