Arbour group
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Arbour Group, LLC is one of a small handful of firms specializing in offering regulatory products and services to the pharmaceutical, medical device and biotechnology industries.
| Arbour Group, LLC | |
| Type | Limited Liability Company |
|---|---|
| Founded | 1989 |
| Headquarters | Chicago, IL - Dublin, IRL - Dubai, UAE |
Arbour Group has an extensive practice in FDA part 11[1] 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'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.
[edit] References
- ^ http://www.fda.gov/ora/compliance_ref/part11/ : FDA 21 CFR Part 11. Retrieved 6/20/2006
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