Specifically engineered to meet your needs from pre-clinical to small-scale commercial manufacturing, we have specialist facilities and expertise for handling highly potent compounds and controlled substances.
We have dedicated suites in our drug product formulation and analytical development laboratories designed for the handling of HPAPIs and a specialized GMP manufacturing plant built as a high containment area.
Our laboratories feature 100% air renewal and the necessary personal protective equipment and other measures in place to guarantee the safety of our operators and the secure handling of your potent products.
We deliver GMP manufacturing of highly potent drugs in a dedicated facility with clean rooms that meet EU-GMP class C standards (ISO 7, US FED STD 209E class 10000 equivalent).
At the start of each development or manufacturing project, we carry out a thorough risk analysis of your active substance, ranking its operational exposure level (OEL) or band. We take into consideration the characteristics of our facilities and equipment, as well as the necessary personal protective equipment and the properties of the active substance to determine that we can safely handle your materials.
In most circumstances, we can work with substances in categories 1 to 4 (up to OEL of 0.1 µg/m3), which comprise the overwhelming majority of HPAPIs and products.
We have the facilities, processes and expertise to develop and manufacture drug products with controlled substances for medical use that fall in the Schedule 2 through 5 categories, meeting all regulatory storage, testing and handling requirements.
Drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence.
Drugs with a moderate to low potential for physical and psychological dependence.
Drugs with a low potential for abuse and low risk of dependence.
Drugs with lower potential for abuse and include preparations containing limited quantities of certain narcotics.
Our expert team members share deep, scientific understanding and insights into manufacturing highly potent and controlled substances.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.