Quality Chemical Laboratories (QCL) serves the biopharmaceutical industry. We provide expert and cGMP compliant scientific testing services in support of both small and large-molecule drug products, drug substances, in-process materials, and raw materials in all phases of Research, Development, and Commercialization. QCL provides formulation development and solid dose GMP manufacturing supporting early-phase clinical trials. QCL is adding sterile fill/finish and lyophilization services launching in 2024.
Our business strategy has been consistent since the company’s inception in 1998. We hire talented scientists and support staff, enabling them to focus on science and on-time delivery while maintaining a high level of quality output. The result of our philosophy has created both customer loyalty and sustainable organic company growth.
Laboratory management and senior scientific staff are deeply experienced in their areas of expertise providing high levels of consultative technical service to customers and opportunities for learning and advancement with their staff. QCL is known for responsiveness to customer needs, flexibility in our approach, and essential project communication from scientist to scientist.
Areas of expertise include:
Small and large molecule analytical development and validation, sample analysis, residual solvents analysis, organic/synthetic chemistry, compendial testing, wet chemistry, trace metals analysis, mass spectroscopy, microbiology, stability management services, formulation development, and clinical scale GMP manufacturing.
Custom Synthesis capabilities are a core competency. Both R&D and GMP synthesis are available in a milligram to kilogram scale. Drug impurity identification, isolation, synthesis, and characterization of high-purity reference materials are core competencies.
QCL works with pharmaceutical customers ranging from virtual companies to many of the top global pharmaceutical corporations. We are FDA and DEA registered and inspected. The data generated on behalf of customers are included with regulatory submissions in support of drug approvals by FDA and international regulatory agencies as well as sustaining existing drugs in the market.
Give us a call today to discuss your project requirements. We would be happy to host you for a QCL site visit or audit when the time is right. Thank you.