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  Judge Research Validation & Compliance

Judge Research offers full service capabilities in biometrics, clinical data management and clinical operations. Our team of technical and scientific experts can bring the knowledge and experience necessary to assist the R&D efforts of our clients across a broad spectrum, including large pharmaceutical, biotech, medical device and research institutes.

Validation & Compliance

To ensure business continuity and compliance with regulatory guidelines, Judge Research offers a comprehensive line of Validation & Compliance service offerings to our life science clients. Our interdisciplinary team of subject matter experts is well-versed on the most up-to-date guidance from the FDA and can bring a practical understanding of the guidance required to protect the large pharmaceutical, biotech and medical device environments.

Validation & Compliance capabilities cover the full range: 21CFR part 11, Part210/211, GAMP4, Part 320, Part 820, Part 58

Across the full spectrum of environments: GMP, GLP, GCP, ICH, GxP, CSV, Equipment/Utilities/Facilities, Cleaning and Process.

Experienced Consultants

The Judge Research consulting practice enlists senior level talent from the top pharmaceutical and biotech companies in the world. This inter-disciplinary team is experienced in all phases and types of clinical studies:

 Pre-clinical
 Phase I
 PK/PD
 Phase II & III
 Phase IV & Post-Marketing
 High level Policies, Procedures and Guideline development
 SOP Review, development and update
 GAP Analysis
 Remediation plans
 Corrective Action/Consent Decree prevention
 Risk Analysis and Management
 Internal/External Audits, including mock audits
 21 CFR Part 11 interpretation and guidance
To learn more about our Judge Research Validation & Compliance services visit (www.judgeresearch.com)
 
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