CDMO Vendor Selection, Qualification & Oversight

For many emerging and small drug development companies, in-house manufacturing of pharmaceutical materials for clinical trials isn't feasible due to lacking infrastructure.

Consequently, they rely on Contract Development and Manufacturing Organizations (CDMOs) equipped with the necessary systems and infrastructure. However, navigating this process isn't straightforward.

Manufacturing Drug Substance (DS) and Drug Product (DP) in compliance with current Good Manufacturing Practice (cGMP) is crucial for successful Investigational New Drug (IND) or marketing application submissions. Unfortunately, small companies often select a CDMO without fully grasping the technical and regulatory challenges involved.

Challenges in selecting or overseeing CDMOs include long lead times, understanding U.S. filing parameters, potential microbial contamination, scale-up issues, and inadequate raw materials control programs. Addressing these challenges often demands significant time and financial investment beyond the service agreement with the CDMO.

Engaging with us mitigates these risks. Our Regulatory Chemistry, Manufacturing, and Controls (regulatory CMC) experts help select CDMOs, establishing productive relationships and ongoing process support. Once assigned, our team collaborates closely with you and your chosen CDMO to meet timelines, manage costs, and advise on regulatory strategies.

The benefits of working with Halloran extend beyond expertise. Our seasoned regulatory CMC professionals cover a wide range of therapeutic modalities, ensuring comprehensive support. With a solid track record across all development stages and lifecycle maintenance, we assist you in bringing new medicines to patients and building value throughout the drug development process.