Regulatory Specialists
Fullerton, United States (US) · Health and Medical
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Last verified
May 2026
#fda
#quality systems
#health canada
#notified bodies
#ce mark
#clinical trials
#submissions
#international
#medical device
#pharmaceutical
Overview
Regulatory Specialists is a Fullerton, California-based regulatory consulting firm specializing in FDA and international medical device, diagnostic, and pharmaceutical compliance.
We simplify the complex regulatory landscape for companies seeking to bring innovative products to market quickly and efficiently. Our team of experienced consultants provides comprehensive support across the entire regulatory lifecycle, from initial submissions to ongoing compliance management.
Founded in 1989 by Greg Holland, Regulatory Specialists, Inc. combines decades of expertise with a commitment to delivering cost-effective solutions. We offer a range of services including 510(k) submissions, CE Mark documentation, clinical trial support, quality system development, and internal audits, ensuring your products meet the highest standards and achieve market approval.
With a proven track record and a dedication to client success, Regulatory Specialists, Inc. is your trusted partner for navigating the challenges of global regulatory compliance.
We simplify the complex regulatory landscape for companies seeking to bring innovative products to market quickly and efficiently. Our team of experienced consultants provides comprehensive support across the entire regulatory lifecycle, from initial submissions to ongoing compliance management.
Founded in 1989 by Greg Holland, Regulatory Specialists, Inc. combines decades of expertise with a commitment to delivering cost-effective solutions. We offer a range of services including 510(k) submissions, CE Mark documentation, clinical trial support, quality system development, and internal audits, ensuring your products meet the highest standards and achieve market approval.
With a proven track record and a dedication to client success, Regulatory Specialists, Inc. is your trusted partner for navigating the challenges of global regulatory compliance.
Contact Details
+19492620411
sales@regulatoryspecialists.com
Fullerton, United States (US), 628 El Mirador Dr
+1
Founded
1989
Company Type
Private Limited Company
Employees
50-100
Keywords
#fda
#quality systems
#health canada
#notified bodies
#ce mark
#clinical trials
#submissions
#international
#medical device
#pharmaceutical
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