In the pharmaceutical industry, Chemical Research & Development (CRD) plays a central role in discovering, designing, and optimizing drug substances. CRD is responsible for developing efficient and scalable synthetic routes, and ensuring that drug substances meet stringent quality, safety, and regulatory standards. The function works closely with Analytical Development, Formulation, and Manufacturing teams to advance molecules from early research through process development and into commercial production.
Key Deliverables
- Synthesis of library of compounds, to identify the lead candidate for pre-clinical studies
- Robust synthetic routes and laboratory-scale processes suitable for scale-up
- Characterization and analytical data packages, including impurity profiling and material specifications
- Stability and compatibility studies to support formulation development
- Technology transfer documentation for pilot and commercial manufacturing
- Regulatory support materials, such as CMC (Chemistry, Manufacturing & Controls) sections for IND/NDA/DMF filings