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.