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The FDA has determined that all Generic Drug User Fee Amendments, GDUFA IV through VI, pass the three-prong test for public interest and they have remained mandatory. FDA has determined that GDUFA VII will pass the three prong test for public interest and surveys evaluating GDUFA VII's public interest have found overwhelming support for the Amendment.
By using standard-authored standards, The BSI Group companies can offer most of the quality assurance services appropriate to your needs but not with the expertise, experience or commitment of a BSI Accredited Body, Assurance partner.
What qualifications does an Assurance partner need?We must qualify as an Accredited Body in our specific area of audit, assessment, assurance, testing, security, standards certification, quality systems, quality management, regulatory, and training.
The BSI Group of companies work in very large markets, with recently over 2 billion people in formal international trade. BSI does not have small business in mind. We are not in the business of trying to get into small businesses or provide them with expertise which they do not need. We provide large enterprise or commercial business customers with the skills, experience, and understanding to improve their business results through the use of standards. As an accredited certification body, we work with all the major companies in our market. We have all the skills, knowledge, experience, and understanding to assist manufacturers in their quality management systems.
Why choose us?The BSI Group companies are based in the United Kingdom and registered to trade in the UK. Our companies were founded by an employee who wanted to offer our company's services outside the United Kingdom and found the UK had no equivalent organizations.
In addition to the TruTops Boost controller, the TRUMPF TruTool software is also available to many future customers for the innovative TruForm: this includes the TruForm Plus Compounder, TruForm Plus Cabinet-Maker and TruForm Plus, which is a complete solution. d2c66b5586