High potency and controlled substances

Recent advancements in drug research, particularly in areas like oncology, inflammatory diseases, and antiviral treatments, have driven the development of new therapies using potent compounds and controlled substances. 

Our cutting-edge research and development laboratories, along with Good Manufacturing Practice (GMP) facilities, are designed to accommodate your need to handle high-potency and controlled substances throughout all stages, from pre-clinical trials to small-scale commercial production. We have the expertise and infrastructure necessary to manage highly potent compounds with an Occupational Exposure Limit (OEL) as low as 0.1 micrograms/m³ (Occupational Exposure Band 5, OEB 5), in addition to holding licenses for the storage and processing of Schedule I – V controlled substances.

Our in-house capabilities encompass expert drug substance development, advanced Solid-State Research and specialized formulation development, ensuring a streamlined process for the development of high-potency and controlled substances from initial concept to commercialization. Our Quality by Design (QbD) approach involves a comprehensive understanding of the physicochemical properties of drug substances, rigorous risk assessments, process design, mitigation strategies, and ongoing evaluation of new data to secure the long-term success of your product. 

This integrated strategy supports seamless transitions into clinical programs while upholding the highest quality standards throughout the manufacturing lifecycle.