Quality Professionals at ACL Digital Life Sciences have proven and high-quality experience in all types of good practices (GxPs). We assist clients with vendor qualification, selection, auditing, review, and management of quality agreements. Furthermore, we have extensive experience leading sponsor inspections by health authorities in the United States and Europe, as well as mock inspection preparation.
Our clinical expertise includes establishing and maintaining good clinical practice compliance programs for all phases of drug development. We also have broad experience with GCP compliance audits of clinical sites, clinical laboratories, drug safety databases, data management centres, and contract research organizations.
Our 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
- Preparation/modification of corporate SOPs relevant to the phase 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
- PAI readiness assessment and training