Research Service Areas

The Research Projects/Services for Our Clients Include, But Are Not Limited to, the Following:

Pharmaceutical Industry

• Research and product development: plan/planning
• Global due diligence for drugs, biologics, or biosimilars
• Patents (licensed to practice in patent cases before the USPTO)
• Business consulting with 360 degree view
• Mapping regulatory issues/pathways
• Market trends
• Labeling requirements
• Regulatory documentation/submission/clearance/approval/registration
• Post-marketing requirements
• FDA advisory committee meeting discussion
• Registration and listing with the FDA
• FDA enforcement matters
• Best practices
• Inquire any other project HERE.

Medical Device and IVD Industry

• Research and Product Development
• Design and Development Plan/Planning
• Global Due Diligence for Medical Devices including In Vitro Diagnostics
• Patent Matters (Licensed to Practice in Patent Cases before the USPTO)
• Business Consulting with 360 Degree View: Market Trends, Labeling, Reimbursement, etc.
• Clinical Evaluation/Report
• Risk Analysis/Management
• Mapping Regulatory Issues/Pathways
• Regulatory Documentation/Submission/Clearance/Approval/Registration
• Post-Marketing Requirements
• FDA Advisory Committee Meeting Preparation, Strategy and Discussion
• Registration and Listing with the FDA
• FDA Enforcement Matters (Product Recalls, Import Alerts, MDRs, FDA Inspection, 483s, Warning Letters, etc.)
• Inquire for any other projects.

Food, Cosmetics, Tobacco and Others

• Please inquire us by email at info@regulatorydoctor.us

Other Information

• FDA Guidance
• Current Good Manufacturing Practice Requirements for Combination Products
• FDA 1572 Statement of Investigator
• FAQs for FDA 1572
• INSTRUCTIONS FOR FILLING OUT FORM FDA 1572

Last Updated: 2016-10-22