Premier Consulting has deep quality expertise in all types of good practices (GxPs). We assist clients with vendor qualification and selection and with auditing, review, and management of quality agreements, and we have firsthand experience with the design, construction, and validation of manufacturing facilities. Additionally, we have considerable experience leading sponsor inspections by health authorities in the United States and Europe, including mock inspection preparation. Our clinical quality expertise includes establishing and maintaining good clinical practice compliance programs for all phases of drug development. We also have extensive experience with GCP compliance audits of clinical sites, clinical laboratories, drug safety databases, data management centers, and contract research organizations.
Core Competencies
- Quality documents
– SOPs, document systems - Quality assurance
– Document review, drug release, audits - Quality control
– In-process controls, validation - Quality issue management
– Investigations, deviations, OOS, CAPAs
Services
- Quality management system (QMS) development
- Preparation/revision of corporate SOPs appropriate to the stage of product development
- GxP audits: vendors, suppliers, study sites
- Establishment of quality agreements and manuals
- QA review of master/executed batch records, specifications, test methods, validation and stability protocols, and reports
- Inspection Readiness Program: a comprehensive program that educates, prepares, challenges, and evaluates adherence to FDA regulations via instructor-led training courses, site assessments, and a mock inspection.
