Pharmaceuticals & Biologics

Early input and learning from those who have already successfully navigated the R&D, clinical, and regulatory path to commercialization can be key to your drug discovery and development efforts. API empowers innovators to reach the market by providing services designed to navigate the drug development process.

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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

  • Regulatory & Quality

    In the ever-evolving life sciences industry, ensuring compliance with regulatory standards is critical for successful…

  • Sterile Fill Finish

    From small-scale clinical batches to large-scale commercial production, our cGMP-compliant facilities are equipped to handle…

  • 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.

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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.