Clinical Trial & Regulatory Services
Complete Services from IND Submission to Clinical Studies
CLINICAL TRIAL & REGULATORY SERVICES
BioKey’s regulatory team helps clients by providing regulatory affairs support, IND submissions, maintenance of IND & BLA applications, and performance of clinical studies.
Clinical Trial & Regulatory Capabilities
- Protocol Design
- Statistical Analysis
- Plan Site Identification and Recruiting
- Site Regulatory Compliance Monitoring
- Patient Recruitment
- Trial Master Files Inventory Management
- Tracking of Specimens and Shipments
- ANDA/IND Submissions
- FDA US Agent Representation & Communications
- GDUFA Self-ID
- Establishment Registration
- Product Listing
BioKey's facilities are cGMP certified.
