criterion is a southern California-based consultancy providing Quality Assurance and Regulatory Compliance services to innovative Pharma, Biotech and Medical Device manufacturers across the United States and its territories.
criterion is a southern California-based consultancy providing Quality Assurance and Regulatory Compliance services to innovative Pharma, Biotech and Medical Device manufacturers across the United States and its territories.
We partner with each client to develop the strategies needed to meet your organization's Quality goals, whether you're a start-up or an established commercial operation.
We partner with each client to develop the strategies needed to meet your organization's Quality goals, whether you're a start-up or an established commercial operation.
Advice rooted in science and driven by innovation
Advice rooted in science and driven by innovation
Areas of Practice:
Areas of Practice:
Regulatory Compliance Services
Regulatory Compliance Services
Quality Assurance Services
Quality Assurance Services
Third-Party Operational Oversight
Third-Party Operational Oversight
Compliance Risk Mitigation
Compliance Risk Mitigation
Quality Management Systems Implementation and Maintenance
Quality Management Systems Implementation and Maintenance
Quality Audits and Mock Pre-Approval Inspections
Quality Audits and Mock Pre-Approval Inspections
Expertise in highly regulated environments such as:
Expertise in highly regulated environments such as:
Pharmaceuticals, Biotechnology, Cell Therapies and Medical Devices
Pharmaceuticals, Biotechnology, Cell Therapies and Medical Devices
USA/EU cGMP regulations - ISO Standards - ICH Guidelines
USA/EU cGMP regulations - ISO Standards - ICH Guidelines
contact: info@criterion.llc
contact: info@criterion.llc
