Chemistry Manufacturing Control (CMC) directly impacts the success of your (pre)clinical studies by making sure pharmaceutical products meet quality, safety, and regulatory requirements. Our CMC pharmaceutical expertise helps streamline your development and manufacturing of clinical trial material, also known as investigational medicinal product (IMP), while ensuring compliance with regulatory standards such as GMP, GLP, and ICH guidelines.
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Tailored pharma CMC solutions
We offer tailored pharma CMC solutions across three key areas.
Quality control
- Development and validation of quality control methods
- Quality assurance and stability studies (purity, binding properties)
- Validation of assays for drug product release (HPLC, etc.)
- Stability testing of pharmaceutical products
IMP manufacturing
- Clinical trial material (CTM) and small-batch manufacturing (GLP/GMP)
- QP release of (radiolabeled) drug products for clinical trials
- Fluorescence/radiolabeling method development and validation
- Radiosynthesis and GMP synthesis of precursors for labeling
- CDMO selection and management for clinical trial material
Regulatory and strategy
- CMC regulatory support for clinical development
- Preparation and review of IMPD/IND for CTA submissions
- Development of protocols for method validation
- Stability study design and evaluation
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Radiochemistry & CMC for imaging studies
As a imaging CRO, we are specialized in Chemistry Manufacturing Control (CMC) for imaging studies, including labeling with radionuclides and fluorescent dyes. We cover the entire process, from developing labeling strategies and optimizing compound labeling in GMP facilities to setting up, validating, and qualifying quality control assays for the release of labeled compounds. Additionally, we conduct comprehensive stability studies, assessing (radio)chemical purity, binding properties, and radionuclide dissociation to ensure the quality and reliability of your imaging agents.
CMC Project Management
With our extensive expertise in CMC pharmaceutical solutions and a specialized focus on imaging studies, we are committed to supporting your clinical development from early-stage research to GMP-compliant manufacturing. By providing high-quality clinical trial material and ensuring regulatory compliance, we help accelerate your (pre)clinical studies and deliver reliable, data-driven results. Whether you require tailored quality control strategies, optimized IMP manufacturing, or expert regulatory support, our team is ready to guide you through every step of the CMC process.
Learn more about CMC, contact us for more information.
Abbreviations
| CMC | Chemistry Manufacturing Control |
| CTM | Clinical Trial Material |
| IMP | Investigational Medicinal Product |
| GMP | Good Manufacturing Practice |
| GLP | Good Laboratory Practice |
| ICH | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use |
| HPLC | High-Performance Liquid Chromatography |
| QP | Qualified Person |
| CDMO | Contract Development and Manufacturing Organization |
| IMPD | Investigational Medicinal Product Dossier |
| IND | Investigational New Drug |
| CTA | Clinical Trial Application (or Clinical Trial Agreement) |
| CRO | Contract Research Organisation |