Categories
Business

Macro Environment factors

Legal:

The manufacturing, marketing, and development of biological products are based on regulations created by regulatory bodies such as Canadian Food Inspection Agency. These regulations tend to be extensive and complex than those applied to other pharmaceutical products. As a result, the oversight and regulatory review process may have an impact on production and create schedules for our products largely than other products (Miller and Cross 56). Moreover, various regulatory and legislative bodies are considering whether to follow an abbreviated approval or follow similar versions used on already existing products. It is not clear as to when or which process may be adopted and how the selected process may affect the processes involved in biological products. Nonetheless, such processes may have a material impact on future financial position for biological products that are patented in Canada (Smith 81).

Environmental:

The company has environmental liabilities some formerly or currently leased, owned and some are third party. We have carefully managed the above liabilities through designated business, legal and technical personnel thus there is no reason for the company to claim that future and current risks and expenditures are likely to affect adversely the company’s financial status. There is a possibility that they could have a materially negative impact on the financial condition, thus affecting the relevant operations of the company (Miller and Cross 88).

Additionally, this impact can be caused by changes made to applicable regulations and law. However, a significant incident or non-compliance for which the company is responsible may make us liable to pay remediation, fines, or compensation costs. In some cases, these liabilities could adversely affect the company’s reputation, operations, or financial condition. Additionally, the company’s financial provisions for any liability associated with the environment may not be sufficient if the assumptions surrounding the environment prove to be wrong. This could be worsened if the company is held responsible for extra contamination (Smith 144).

Wok Cited

Miller, Roger & Cross, Frank: The Legal Environment of Business: Text and Cases: Ethical,        Regulatory, Global, and Corporate Issues. California: Cengage Learning, 2011 print.

Smith, Mickey: Pharmaceutical Marketing: Principles, Environment, and Practice. New York:   Routledge, 2002 print.