Validation and Compliance Solutions

Innovative Solutions Provider for FDA Regulated Industries

PGC’s Validation Group is dedicated to providing regulatory compliance and validation services to FDA regulated industries. We oﬀer our clients a unique blend of technical expertise, regulatory compliance insight, and pratical hands-on operating experience. PGC’s validation group has the resources to meet your project needs in the most cost-eﬀective manner. PGC provides specialist teams with the experience and capability to perform the necessary service based on project requirement using the applicable cGMP’s to ensure compliance. We can provide validation support at any level, either as augmented support for part of a project or a complete turn-key solution.

Our People

The unrivalled expertise, experience, and commitment of our people make them our greatest asset. We actively seek out professionals who are specialist in their ﬁeld and we combine this with a deep understanding of our clients’ needs. Our staﬀ has direct work experience in the full spectrum of industry environments. Our associates have worked in R&D, analytical labs, development pilot plants, clinical manufacturing suites, and large scale commercial production facilities, under all auspices of the relevant GXP’s. We received our training and gained expertise at some of the most successful compaines in the industry. All of our associates have a solid scientiﬁc background including Engineering, Life Sciences, or Chemistry.

Range of Services

PGC’s validation group has experience managing and executing projects from stand-alone automated equipment and systems to start-up, commissioning, and validation of new facilities. We can document that the equipment and systems operate as designed and speciﬁed prior to start of formal validation activities.

Services Include

Policy and Procedures Deployment
Validation Gap Assessments
Validation Master Planning
Protocol Development and Execution
Documentation Management
Change Control
URS, FRS, IQ, OQ, PQ, and Final Reports
Commissioning and Startup Programs
Equipment, Facilities, and Utilities Qualiﬁcation
Process Validation
Laboratory System Validation
Stability Chamber Qualiﬁcation
Revalidation and Re-qualiﬁcation
Validation Life Cycle Methodology

Validation and Compliance Solutions

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