Scale-Up Blog Series, Part 3
[Editor’s note: Scale-up is an inevitable part of the product life cycle of every successful drug, and each time it is required, a meticulous process must be followed to ensure that the end result is identical to the product formulation as originally devised. This is part 3 of an in-depth, multi-part series on product scale-up. Visit our blog page to read parts 1 and 2.]
Doing business in Canada offers tangible business benefits. In any country, contracting contract manufacturing services requires managing the legal and regulatory aspects particular to that country; fortunately maintaining a commercial relationship across Canadian borders is generally simple and straightforward. Canada offers pharma companies an ideal platform from which to access European and other markets as part of an international business strategy.
There is a common misconception that controlled substances won’t be allowed to cross the Canadian border, thus preventing some pharmaceutical products from being produced by Canadian contract manufacturing facilities. We need to move past this fallacy. There are many proven ways to manufacture controlled substances in Canada, provided the products are in compliance with import/export regulations in their home nation. Even if the substance is banned in Canada, Canadian regulators permit such commerce to proceed with minimal bureaucracy and legal red tape.
If you are like most managers responsible for green-lighting a CMO partnership, making the decision to choose one supplier over another can be career changing. Making these decisions confidently depends on how well the selection process narrows the field of prospects to a manageable group of strong contenders.