Global, FDA Regulatory Consulting for Medical Devices, Drugs and Other Products


Author: Admin

We are a global leader in providing regulatory affairs, quality, clinical affairs, and regulatory compliance consulting in the following areas. We daily strive to provide you with the Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough (“PASS-IT”) manner, helping you make an informed decision.

Our Expertise Click Here to Read about Our President and Principal

Please watch a video introduction about Regulatory Doctor Services

Appreciation and Awareness for Your Needs

While working at the United States Food and Drug Administration (FDA), Dr. David Lim, 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.

Our Areas of Expertise

Global Regulatory Consulting | Quality & Clinical Consulting | Regulatory Consultants | Management Consultants | Medical Devices | IVDs | FDA 510(k) | PMA | QSR | MDR | CAPA | ISO 13485 | ISO 14971 | MDD | AIMDD | IVDD | CE Marking | Biologics | Biosimilars | Drugs (Human and Animals) | Combination Products | Dietary Supplements | eCTD | FDA (BIMO) Inspection | Risk Management | Pharmacovigilance.

Our Consulting-360 Degree ViewsBenefits 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
  • Global Due Diligence for Drugs, Biologics, Biosimilars and Medical Devices including In Vitro Diagnostics
  • Patents (Licensed to Practice in Patent Cases before the USPTO)
  • Business Consulting with 360 Degree View
  • Mapping Regulatory Issues/Pathways
  • Regulatory Documentation/Submission/Clearance/Approval/Registration
  • Post-Marketing Requirements
  • FDA Advisory Committee Meeting Discussion
  • Regulatory Issues for Drugs, Biologics, and Medical Devices
  • Registration and Listing with the FDA
  • FDA Enforcement Matters (Product Recalls, Import Alerts, MDRs, FDA Inspection, 483s, Warning Letters, etc.)

We Provide Direction and Guidance.

Direction and Guidance

Our Expertise Also Includes Our Systematic, Integrated Assistance and Support During Product Liability Litigation.

  • Perform Serious Research on the Legal Issues
  • Case Analysis and Expert Opinions
  • Assistance in Your Trial Preparation
  • Expert Testimony in Court

As a global leader, our 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. With our 360 degree views and perspectives, we provide PASS-IT guide to the global healthcare industry.

We also provide highly selective, customized, and focused global compliance seminars.

Update: March 30, 2014

Implementing UDI Systems - Global Compliance Seminar