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.

Our Consulting-360 Degree Views

 

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

Last Updated: 2016-10-22