Regulated Industry Services:

Quality & Regulatory Compliance Services

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements, specifications, and standards. Quality systems for FDA-regulated products; i.e. 21 CFR 210, 21 CFR 211, 21 CFR 820, 21 CFR 110, etc. (food, drugs, biologics, and devices), are known as current good manufacturing practices (cGMP's).

The applicable quality system requirements for international standards published by the International Organization for Standardization; i.e. ISO 9001:2008, ISO 13485:2003, ISO 100006, are the widely accepted standard requirements used today.

Allegiant's job is to provide consultancy and experts to work with clients to address their specific needs. Allegiant provides customized services to, and specifically designed for: small companies, midsized firms, large organizations, and virtual organizations. Clients expect and receive services that are high-impact, reasonably priced, value-added, and highly effective. Allegiant prides itself on our approach, which includes working in collaboration with our clients and taking a "hands on" approach to deliver results. We take ownership in your success by providing:

    o FDA/ISO Assessment, Inspection, Audit, & Gap Analysis Services
    o Program/System Planning & Design Services
    o Program/System Development Services
    o Implementation Services
    o Interim Management
    o Development of SOPs
    o Development of Metrics
    o Training & Knowledge Transfer Services
    o Supplier Qualification & Auditing Services
    o Experienced Personnel to do the work required
    o And More. . . Call to inquire today!

E-mail: info@allegiantworks.com