Services
Virtuoso CMC Consulting helps pharmaceutical companies navigate complex drug product development challenges with practical judgment, technical depth, and disciplined execution.
Formulation & Process Development
Practical, phase-appropriate small molecule formulation and process development support, with emphasis on developability, manufacturability, scalability and clinical-stage execution. Experience spans conventional immediate-release formulations through more complex oral dosage forms, including solubility enhancement, controlled-release, sustained-release, and gastro-retentive systems.
Technical Due Diligence
Assessment of technologies, products, development programs, and external partners to support licensing, acquisition, investment, and strategic decision-making.
CMC Strategy
Integrated drug product CMC guidance to help companies make sound technical decisions, anticipate development risks, and align formulation, manufacturing, testing, and program timelines.
Clinical Manufacturing & Technical Transfer
Support and management of clinical manufacturing activities, troubleshooting of execution issues, and preparation for later-stage development. Guidance for transferring drug product processes into appropriate domestic and international manufacturing environments.
CDMO Selection & Management
Support for CDMO selection, technical due diligence, RFP preparation, proposal review, pricing evaluation and negotiation, and oversight of outsourced drug product development and clinical manufacturing activities.
Have a development challenge or program need in mind?
Let’s discuss how Virtuoso can help.