Controlled Substances

Safe and secure controlled substance manufacturing

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. Due to their complex nature and the stringent security measures required to handle controlled substances, 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. Our expertise in analytical chemistry and cGMP manufacturing enables us to safely handle controlled substances throughout the entire product lifecycle – from preclinical development to commercial scale.

Things that contribute to our strength in controlled substance manufacturing

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Comprehensive experience:

We apply our extensive experience importing, storing, manufacturing and exporting controlled substances to every project involving scheduled materials.

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Full-lifecycle perspective: 

As a full-service outsourced partner, we are capable of scaling up our customers’ controlled substance projects from grams to tons.

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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.

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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.

What are some controlled substances challenges pharmaceutical organisations face?

In order to work with controlled substances, organisations must obtain the appropriate licenses to hold and handle different types of substances, which requires a specific infrastructure and successful audits from authorities. In addition to obtaining the relevant licenses, organisations must maintain thorough documentation around the controlled substances they have on site, the quantity of each type, and how they are handled. This documentation must be ready and available to provide to regulators upon request.

Safes and storage areas that hold controlled substances must be monitored, and only authorised users can handle controlled substances at any given time.

 

Organisations must keep highly detailed records of the controlled substances they have on hand, and how they are handled or utilised. This also applies to any controlled raw materials used to manufacture a final product.

Controlled substances also bring special considerations when it comes to waste disposal. Waste streams containing controlled substances must be documented, and additional analysis is typically required to determine assay values of the substance in the waste.

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.

Mathew Minardi | EVP of Global Project Management

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