Appreciation and Awareness for Your Needs

While working at the United States Food and Drug Administration (FDA), our President, CEO and Principal came to the realization that the unique and distinct consulting services are needed to bridge the gaps and to connect the dots between industry and global regulatory health authorities with appreciation and awareness of current and future needs.

REGULATORY DOCTOR was founded based on such vision.

Benefits to the Community and Industry

REGULATORY DOCTOR offers unique and outstanding benefits to its clients based on extensive expertise in many areas built on over 25 years.

Our Expertise Includes, but Is Not Limited to:

• Research and Product Development
• Design and Development Plan/Planning
• Patents
• Mapping Regulatory Issues/Pathways
• Regulatory Documentation/Submission/Clearance/Approval/Registration
• Post-Marketing, etc.

REGULATORY DOCTOR is a leading firm in global regulatory affairs, clinical affairs, and quality training, consulting and coaching.  Regulatory Doctor’s services include, but are not limited to, drugs, biosimilars, FDA 510(k) and PMA submission, HDE, pre-IDE and IDE, quality (QSRs and ISO 13485), GLP, GCP, cGMP, CE marking as well as global compliance matters.

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REGULATORY DOCTOR™ is led by Dr. David Lim, Ph.D., RAC, CQA-ASQ, regulatory coach, mentor, FDA consultant, and public speaker, who is also referred to as regulatory doctor.

For consulting inquiries, please fill out the form below.