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Tim Rosa Associates understands the pressures faced by companies in healthcare markets, including life sciences, discovery genomics, biotechnology, pharmaceuticals, and medical devices. Every day we help healthcare companies successfully tackle complex communications assignments and develop documentation that demonstrates compliance with the demanding regulations of the U.S. Food and Drug Administration (FDA) and other global regulatory agencies in Canada, Europe, and Japan.
Take a look at what we've accomplished for some of our recent healthcare clients:
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ACTIONS
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RESULTS
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Edited more than 40 validation documents (VMP, URS, FS, DDS, IQ, OQ, PQ, and others) for two compliance projects.
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Helped Millennium to improve the overall quality, consistency, and presentation of the documents and demonstrate compliance with 21 CFR Part 11.
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Edited two technical summary reports to be included in the company's pre-IND package; made recommendations for consistent content, format, and presentation of all written materials.
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Helped Archemix to improve the quality and writing efficiency for their documents to facilitate the U.S. FDA's review of the company's IND dossier.
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Created a training plan and Help Desk training module as part of the company's Technology Transfer Program; developed a Quick Start Guide for the company's wireless handheld product.
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Helped PHT address critical customer needs for new and existing pharmaceutical sponsors and end-users engaged in clinical trials.
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Wrote an Installation Qualification for the management software of an automated laboratory system. Used an existing IQ template of FMI and recommended content changes to improve the template and final deliverable.
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Helped Foster-Miller to install, configure, and test the software at the site of their major pharmaceutical sponsor.
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