Our Services for Highly Potent & Controlled Substances
Whether it’s highly concentrated active pharmaceutical ingredients (APIs), chemicals or naturally sourced controlled substances, our facilities offer full-scale solutions from clinical to commercial production. With our full cGMP facilities and capabilities, we ensure quality, consistency and compliance throughout the active compound development lifecycle and are supported by the following licences:
- Health Canada Drug Establishment License
- Health Canada Licenses for Restricted Substances
- Health Canada License for Natural Health Products
- Health Canada Cannabis License
Services Overview
Potent Compound Synthesis
Specialized manufacturing of highly potent chemicals, APIs and natural health products for clinical and commercial use.
Pre-Clinical and Clinical Manufacturing:
Tailored solutions for preclinical and early-stage clinical manufacturing with scalable, GMP-compliant procedures.
cGMP Production
State-of-the-art cGMP laboratories supporting the full development cycle of highly active and regulated compounds.
Stability Studies
Robust stability testing and monitoring under various environmental conditions.
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Get In TouchContract Development Manufacturing Services & Facilities
Clinical Trial Manufacturing
We offer adaptable, high-quality clinical trial manufacturing for small molecule therapeutics, supporting seamless transition from preclinical research through late-stage development. Our phase appropriate GMP facilities—the Drug Development and Innovation Centre on the Katz Group Centre at the University of Alberta and the Biotechnology Business Development Centre (BBDC)—are purpose-built to enable efficient small-batch production, process optimization, quality control testing and stability studies.
Key Facility Features Supporting Clinical Manufacturing
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Biotechnology Business Development Centre (BBDC)
- R&D manufacturing from clinical to commercial GMP production
- Auxiliary R&D lab for formulation and optimization
- Specialized containment and processing equipment including
Buchi Glas Reactors, Nutsche Filters and Gas Scrubber
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Drug Development & Innovation Centre (Katz Group Centre)
- Small-scale small molecule production (up to 10 kg batches)
- Small molecule API production for clinical phase I and II
- Formulation prototyping for various forms of highly potent substances
Why Highly Potent & Controlled Substances Require Specialized Expertise
The production of highly potent and controlled substances is a critical area of pharmaceutical manufacturing—for good reason:
- Precision is Vital: Highly potent substance production involves intricate, multi-step chemical processes, where exacting precision is essential to ensure potency, purity, and safety.
- Expertise, Quality, and Compliance are Essential: Manufacturing these substances demands specialized knowledge—from handling raw materials and optimizing reactions to refining purification, formulation, and analytical testing—all while adhering to strict GMP standards and regulatory requirements.
- Partnering with the right process expert is crucial, as they can guide the entire process—from early-stage development and scale-up to regulatory support and commercial production.
Meet Our Senior Leaders and Contacts
Allan Aginski
Senior VP, Special Projects & Manufacturing
Read bioabout Allan Aginski Allan Aginski
Senior VP, Special Projects & Manufacturing
Allan is a life sciences supply chain and manufacturing specialist with nearly 40 years of experience. He has established and run commercial life sciences company production facilities around the world, including for companies such as Abbott, Merck, and Genpharm. He has been responsible for the establishment of dozens of products in over 24 countries.
Hans Bauer
VP, Technical Operations
Read bioabout Hans Bauer Hans Bauer
VP, Technical Operations
Hans brings over 25 years of experience in pharmaceutical manufacturing and quality, having worked with leading pharmaceutical companies in Europe, including Lonza, Sandoz (Novartis), Acino, and Akorn. He has a proven track record in managing large teams, complex projects, and overseeing comprehensive operations.
Hans has strong expertise in developing and implementing robust quality systems that meet stringent regulatory standards across several countries, including the US, EU, and Switzerland. His production expertise includes API-small molecule manufacturing, peptide chemical and biotechnology manufacturing, as well as the production of solid and semi-solid forms and sterile manufacturing.
Shawn Couch
Director, Business Development
Read bioabout Shawn Couch Shawn Couch
Director, Business Development
Shawn Couch is a seasoned business development and key account management professional with over 20 years of experience in the North American pharmaceutical industry. With a strong track record of surpassing sales targets, he has expertise in drug substance and drug products, including solid oral, and injectables. His career includes business development roles at Corden Pharma, Fabricca Italiana Sintetici and ACIC Fine Chemicals, where he played a pivotal role in expanding market presence and increasing revenue.
Vijay Somayaji
Sr. Director, Product Development & Quality
Read bioabout Vijay Somayaji Vijay Somayaji
Sr. Director, Product Development & Quality
Vijay has over 30 years experience in biotech research and development and QA/QC. With a PhD in Chemistry and post-doctoral work under Nobel Laureate Dr. H. C. Brown, Vijay has served in director level roles at Biomira, AltaRex, Novolytic, and Virexx. As an experienced QA, Vijay has supported product development for dozens of clinical programs taking place at sites around the world.
End-to-End Manufacturing Support
We provide comprehensive manufacturing solutions from preclinical stages to large-scale commercial production. Our integrated approach, combined with our Early Discovery & Development, Regulatory and Quantitative Solutions (QS) teams, ensures a seamless experience at every step of the development journey.
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