Resources
Utilize these quick links to access these essential drug and medical device development resources.
All your go-to resources in one place to support your project every step of the way.
Project Resources
FDA Center for Drug Evaluation and Research (CDER)
FDA approval of a drug means that data on the drug’s effects have been reviewed by the CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.
Learn more about how the drug approval process takes place.
Center for Drug Evaluation Research - Small Business Industry Assistance (SBIA)
CDER SBIA’s mission is to engage with small pharmaceutical business and industry by providing timely and accurate information on human drug development and regulation. CDER SBIA interacts with industry in several ways including webinars, conferences, workshops, and web based tutorials.
FDA Center for Devices and Radiological Health (CDRH)
Device Advice is CDRH's premier text-based resource that explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.
Drug Authorization
Learn about Health Canada drug submission applications, the drug licensing process, drug identification numbers and notices of compliance.
Medical Device Listening
Access Health Canada forms and guidance documents to help you apply for a medical device license. Search for a licensed device using the database.
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