We operate as an extension of your leadership team and deliver executive-level CMC strategy, CDMO management, and comprehensive Module 3 submissions
Our Services
CMC Strategy
Developing an efficient CMC strategy is essential for success
CDMO Management
Selection, qualification, and proper utilization of CDMOs is critical for execution
Module 3 Submission
Module 3 must be written correctly to avoid unnecessary delays in approval
About Us
Frank Blondino, PhD, MBA
Frank has over 30 years of experience in the pharmaceutical industry with a primary focus on small, virtual organizations that rely upon CDMOs to successful 505(b)(2) New Drug Applications.