Changing the World for the Better

As a premier provider of regulatory validation and testing services, Allegiant offers the convenience and economy of one-stop shopping for all your regulatory needs

A number of clients rely on our comprehensive capabilities to outsource their entire validation and testing processes. Others with less extensive needs are able to select the level of service that best meets their individual situation. From a large scope project based need to a focus on a specific single need, our regulatory specialists are at your service. We have the ability to work with your organization and integrate our expertise into your culture. Allegiant has the flexibility to perform our regulatory services at your site or at any location in our worldwide network.

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The FDA has deployed initiatives that include more stringent requirements, a higher volume of inspections, and swifter, heavier penalties for non-compliant companies in federally regulated industries. Compliance issues among manufacturers are becoming rapidly more visible as smaller, less sophisticated manufacturers are consolidated into larger and larger companies. Allegiant has faced these unique challenges working with Fortune 500, as well as small and mid-size manufacturers.

Our experience spans a wide variety of manufacturing, laboratory, and clinical (cGxP) environments including new product/process development, manufacturing design and improvement, clean room development/installation, equipment and tool installation/moves, quality management systems consulting, all forms of validation, and regulatory solutions that encompass 21 CFR Part 210, 211 820, 106, 107, 110; ISO standards including 13485; 21 CFR Part 11; and HIPAA.

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Benefits & Highlights