Joseph Wilcox's Page

In today’s globalized world, competition has increased multifold for most businesses. As globalization brings it with both opportunities and challenges, the marketplace has evolved to a point where it is imperative for companies to become global. This is an opportunity they can ignore at their own peril. International sales should become an essential part of an organization’s business plan.

The cost advantages that accrue from producing overseas, the revenue opportunities from foreign…

The successful launch of pharmaceutical products and their processes is directly related to the success of another factor: their transfer. It is only through successful transfer of these processes that the pharmaceutical company can ensure that its products are not only of the highest quality, but also get delivered to the patients and meet the business demands of the company. Expectedly, the execution of this transfer is not very simple and straightforward. It involves the interactions and…

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up…