Our comprehensive controlled substance services are supported by robust analytical expertise, stringent security controls, cGMP manufacturing capabilities, and regulatory certifications.
Controlled substances at Sterling
Controlled substance manufacturing has seen heightened demand in recent years for therapeutics with strong potential in mental, pain management, and anti-addiction treatments. Because of their complex nature and the stringent security measures required to handle controlled substances, however, it is imperative to work with the right partner on their development and production.
At Sterling, we have the licenses, security infrastructure and expertise needed to safely handle controlled substance manufacturing at scale. We are registered to import, store, manufacture and export controlled substances in both the UK and US to support our global customer community. Paired with these certifications, our expertise in analytical chemistry and cGMP manufacturing enables us to safely handle controlled substances throughout the entire product lifecycle—from preclinical development to a commercial scale. ... Read more
Following are some of the things that contribute to our strength in controlled substance manufacturing:
- Comprehensive experience: We apply our extensive experience importing, storing, manufacturing and exporting controlled substances in the US and UK to every project involving scheduled materials.
- Full-lifecycle perspective: As a full-service outsourced partner, we are capable of scaling up our customers’ controlled substance projects from grams to tons.
- Security infrastructure: To ensure safety and compliance, we have stringent security measures in place for controlled substance handling, including detection systems, vibration controls and more.
- Regulatory relationships: We regularly engage with enforcement agencies on our customers’ behalf to proactively determine when a substance may be scheduled and take the appropriate measures to maximise success. Read less
Key Benefits
When working with the right outsourced partner, controlled substance manufacturing delivers several compelling advantages. These include:
Experience:
A partner with a track record of executing projects in the space and the experience of interacting with key regulatory bodies such as the DEA in the US and MHRA in the UK.
Cost containment:
Working with an experienced partner, who already has the necessary controls in place, avoids the need to invest in added security measures and equipment internally.
Licenses and compliance:
A partner with a strong compliance track record and certifications to work with scheduled substances ensures continued regulatory success.
Supporting regulatory success with controlled substances
To navigate the complexities of controlled substance handling, we offer our customers expertise and guidance to ensure ongoing compliance. In the early stages of our customers’ projects, our close relationship with regulatory agencies enables us to aid in determining whether a substance is likely to be scheduled, and to take the precautionary measures needed to adhere to safety and security standards.
With robust security controls in place, our state-of-the-art facilities in the US and UK are licensed to handle a range of controlled substances:
- Dudley, UK: Licensed by the Home Office to handle Schedule 1-3 controlled substances
- Germantown, US: Licensed by the DEA to handle Schedule I-V controlled substances
- Cary, US: Licensed by the DEA to handle Schedule I-V controlled substances
“As demand for controlled substances has increased, we at Sterling have applied our analytical and regulatory expertise to successfully work with scheduled substances in a variety of customer programmes. We combine our end-to-end services with stringent security measures to safely scale up controlled substance manufacture and enhance our customers’ success.
” Mat Minardi | EVP and Site Lead, Cary
