Arbour Group, LLC is one of a small handful of US firms specializing in offering regulatory products and services to the pharmaceutical,
medical device and biotechnology industries. Regulatory compliance is what ensures that poisonous or adulterated feedstock do not enter into the manufacturing chain. Examples of what happens when the system breaks down include several recent poisoning cases where glycerine has been replaced with diethelyne glycol.



Arbour Group has an extensive practice in FDA part 11<ref>http://www.fda.gov/ora/compliance_ref/part11/ : FDA 21 CFR Part 11. Retrieved 6/20/2006</ref> compliance, a major requirement that has to be fulfilled before they are permitted to enter the US marketplace. The US electronic signature requirements are considered the world's gold standard and thus compliance with the US standard is also accepted by other major regulators. Arbour Group engages in Part 11 certification efforts world-wide with personnel on three continents.

Arbour Group's innovative certification script products allow pharmaceutical and medical device companies using a wide variety of computer systems to quickly get their internal certification efforts up to speed, allowing them to avoid reinventing the wheel. By offering both custom and packaged solutions across a broad variety of platforms, Arbour Group is unique in its field. In 1988, in combination with Agile Software, Arbour Group was the first company to offer a packaged software solution for FDA intended software validation[866].

Arbour Group's regulatory services offer distinct benefits in:

evaluating regulatory compliance

identifying associated risk factors

enhancing productivity via reduction in application development and implementation time

capitalizing on the investment in software systems

improving quality policy and standard operating procedures

providing a qualified, third-party analysis of automated systems

Arbour Group's clients often outsource their entire regulatory validation and testing process, making this company a critical part of the chain from research lab to drugstore shelf.

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