What does API do for pharmaceuticals & biologics?
We provide and connect you with the services and expertise needed for every stage of drug development.
At API, our teams understand the process of pharmaceutical development. We partner with life sciences companies at any stage of the research and development cycle, from CDMO services to clinical trials. As your strategic partner, API will provide access to facilities and experts that will help drive your pharmaceutical projects to successful commercialization. From molecule to market, our team is here to support your journey.
Services for Pharmaceuticals & Biologics
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Regulatory & Quality
In the ever-evolving life sciences industry, ensuring compliance with regulatory standards is critical for successful…
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Topical Application Manufacturing
Topical formulations are applied directly to the skin, allowing for localized delivery of active ingredients.…
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Oral Dosage Manufacturing
Whether your product is a small molecule or a natural health product, our facilities offer…
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Sterile Fill Finish
From small-scale clinical batches to large-scale commercial production, our cGMP-compliant facilities are equipped to handle…
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Small Molecule Manufacturing
Whether your product is a small molecule or a natural health product, our facilities offer…
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Highly Potent Controlled Substances
Whether it’s highly concentrated active pharmaceutical ingredients (APIs), chemicals or naturally sourced controlled substances, our…
Within these services, you can expect specialized support for pharmaceuticals (whether prescription or over-the-counter (OTC) drugs), within the specific domains relevant to the health regulator of your preference:
Regulatory Submissions and Applications
- Clinical Trial Application (CTA) or New Drug Submission (NDS) – Health Canada
- Investigational New Drug (IND)/ New Drug Application (NDA)/Biologics License Application (BLA) – FDA
- Drug Master File (DMF)
- And more
Drug Establishment Registration/Licensing
Grant Writing/Application
Programs for Pharmaceutical Innovators
Here are more resources to get your ideas to market.
In addition to services for the pharmaceutical industry, API has a suite of programs and training resources for innovators looking to commercialize their pharma & biologics ideas. Whether you’re looking for an incubator, network, or life sciences support and training for your business, check out our programs & training hub.
See all programs
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Get in touch
Contact us today to learn how to propel your pharmaceutical or biologics projects with the support of our life sciences commercialization and drug development services in Canada.