Clinical Trial & Regulatory Services

Complete Services from IND Submission to Clinical Studies


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.