SERVICES FOR LIFE SCIENCE MANUFACTURERS
Many of the world’s top life science manufacturers turn to BioTeknica, an IQVIA business, for regulatory compliance, FDA inspection readiness, quality engineering, IT/software quality, and validation services.
- Compliance Audits and Assessments
- Third party Certification
- 483/Warning Letter/Consent Decree Resolution
- Development and Implementation of Quality Systems
- Simulated Inspections
- Risk-Based Preparation
- Inspection Oversight and Management
- Experiential Learning for SMEs
- Discovery
- Training
- Facilitation
- Deployment
- Mentoring
- Operational Excellence
- Quality Issue Analysis
- Root Cause Identification
- Statistical Techniques Evaluation and Optimization
- Development and Implementation of Quality Systems
- Solution Development and Implementation
- Equipment Qualification, Process Validation, Facilities/Utilities Commissioning/Qualification
- Test Method Validation
- PLC/Control System/Computerized Systems and Software Validation
- Validation Master Plans, Procedures, Protocol and Report Templates
ISO 9001 CERTIFIED
Unlike most consulting firms, we are an ISO 9001:2015 certified company with global operations.
ISO 9001 CERTIFIED
Unlike most consulting firms, we are an ISO 9001:2015 certified company with global operations.