Pharmaceutical Regulatory Services
Understanding Pharmaceutical Drugs
Pharmaceutical drugs are either synthetic products made from chemicals or made from Biological
substances. They are meant to improve the health and well-being of patients by helping to prevent
and treat disease, reduce pain and suffering, and extend and save lives.
Some higher-risk drugs, such as those used to treat diseases, require a prescription from a physician.
Other lower-risk drugs, such as cough syrup and antacids, are sold without a prescription and
are readily available to the public. These drugs are considered low risk and are generally considered as Over the Counter (OTC) Drugs
Innovator drugs ("brand name drugs"): Manufacturers receive authorization to sell these products in Canada by submitting a New Drug Application
Subsequent entry drugs ("generic drugs"): Regulators around the world often authorize manufacturers to market drugs that are copies of the original innovator drug by requiring them to submit an Abbreviated version of a New Drug Application. There is a patent period of 8-10 years after the which the generic version of the drug can enter into the market.
Just give a call or send us an email with all your questions and we will be glad to assist. We will typically answer you in 3-4 business days. We are there to assist you in all your Regulatory Requirements. We will first determine if your drug is a Prescription or an OTC Drug. We will next accordingly compile, file and submit your submissions as per the required Regulations for both OTC and Prescription drugs. We have compiled some of the most Frequently asked questions that may answer many of the queries you may have.