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Pharmaceutical products are categorized, by Creechurch, into different groups such as human prescription, human non-prescription, veterinary drugs, over the counter products, cosmetics, food supplements, vitamins, etc. These products can be therapeutic (designed to cure illness) or preventative and can either be manufactured or naturally occurring (holistic). The manufacture, distribution and sale of these products is generally heavily regulated by a government regulatory body such as the Health Protection Branch (HPB) in Canada, and the Food and Drug Administration (FDA) in the United States.

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Biotechnology includes any technique that uses living organisms to make or modify a product. The industry is generally focused on one of the following areas of work: diagnostic [identifying the cause(s) of disease(s)], therapeutic or preventative. Biotechnology would also include companies involved in areas such as DNA sequencing and genomics.

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Medical Devices include various patient care equipment used in the medical field (and may also include some veterinary usage). Risks are categorized by class with ratings based on the revenue breakdown by geographical area: Canada, the United States and all other countries. These devices may be invasive products, (both short term, i.e. needle; and long term, i.e. heart valve), non-invasive (measuring devices, etc.), active devices (X-ray machines), or other specialty products.

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Clinical Trials
In order to be sold to the public, many Healthcare Products must pass through pre-clinical analysis and clinical trial testing, as required by Canadian and U.S. governments. Pre-clinical testing involves testing the chemistry, pharmacology and toxicology of the drug in a laboratory setting. Success at the pre-clinical stage often results in the company progressing to the clinical trials testing phases. In order to undertake a clinical trial, the manufacturer or Contract Research Organization obtains Investigational New Drug (IND) status for the drug or medical device from the regulatory authority, who then reviews these laboratory results. If these are acceptable, they will provide approval including, in the case of a new drug, the assigning of an IND number.

Clinical Trials is usually the first instance where a human will interact with the drug or device. At times, Clinical Trials can be conducted concurrently in various countries, and as a rule, involve three stages:
1. Phase I - the drug is administered to healthy humans to study its toxicity and efficacy on the body (i.e. tolerance, temporary side effects, etc.);
2. Phase II - the drug is administered to a small test group of patients who have the disease or medical condition the drug or medical device is intended to target; and
3. Phase III - the drug is given to a larger group to confirm the statistical data.

At this point if all has gone well for the company it will submit its findings to the government regulators who will review the results to determine: i) if expected results were actually achieved; ii) if it is a practical and cost effective medical advance compared to current treatment methods in place; and iii) if the new drug/device serves the interests of the public to allow the product to be on the market.

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