CMC Development Oversight
Quality Target Product Profile development based on Target Product Profile
- Oral delivery
- Parenteral delivery (SC, IV, intrathecal,..)
- (Trans)dermal delivery
- Nasal delivery
Clinical supply management
Packaging & labeling
Comparator sourcing/ shipment/storage
Pharmacy manual preparation
CMC development strategy
Response to questions
GMP Quality oversight
Management of all CMC-related activities from preclinical phase to late phase development including but not limited to:
Vendor selection / management
Analytical development / validation
Formulation development / process development
Set-up and shelf-life management
Scientific & Regulatory writing
PPQ prep / mgt / quality & scientific risk management
R&D Leader, Scientific Development & CMC
A rigorous and methodical biochemist with solid analytical and CMC skills and over ten years of experience in scientific research. Highly interested in regulatory strategy, has a global view on pharmaceutical project development.
My work/involvement in a project often starts by performing a project gap assessment, which often reveals the tip of the iceberg called “challenges” and helps to reflect on the major project hurdles. It also obliges you to have a global view of combining the bricks of the puzzle into one single big piece. CMC is regarded as the least important point by most of our academic clients. But it involves the tested product that will provide the right pharmacodynamic effect in a human being. It’s what you aim for! You need the right amount of formulated products that fulfill regulatory requirements of the required quality and characterization level from the right API of satisfying purity. Only with this single sentence, I can already involve 4-5 of my colleagues having expertise in quality, analytics, formulation, regulatory, and activities oversight.
”CMC is often underestimated when it has a major project impact, I like to remind colleagues/clients of that!