Proven Success in Biologics Development
Comprehensive Biologics Services
The biologic product development framework brings regulatory challenges and complexities unseen in the traditional pharmaceutical development process. Our expert team is here to guide you through every step.
Regulatory Strategy & Due Diligence
Strategic guidance through complex regulatory pathways and thorough due diligence assessments.
FDA Meeting Preparation
Expert preparation and support for crucial FDA meetings and engagements.
FDA Submissions
Comprehensive support for IND, BLA, and other regulatory submissions.
Nonclinical Development
Strategic planning and oversight of nonclinical studies and programs.
Clinical Development
End-to-end support for clinical trial design, execution, and management.
CMC Development
Comprehensive Chemistry, Manufacturing, and Controls development support.