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.
Last Updated: 2020-06-19