Quality Compliance / Regulatory Compliance / cGMP Audits / Quality Program Development and Enhancement / Validation Program Management /
Facilities Qualifications / Start-up and Commissioning Activities

Quality Compliance Focus

Provide experienced industry leaders to meet customer’s compliance needs.
Specialize in establishing, executing, and implementing customer compliance programs.
Evaluate compliance programs and perform risk assessment and management.

Quality Compliance Experience

Validation Programs
Life Cycle Approach
IQ/OQ/PQ Programs
New and Existing Facility Validation
Equipment Qualification
Process Validation
Sterile and Non Sterile Facilities

Quality Compliance Programs

Change Control
Cold Chain Management
Container Closure Integrity
Leachables and Extractables
Environmental Monitoring
Non Conformance
Customer Complaints

Quality Compliance Programs Developed

QA Program Development
Change Control
Cold Chain Management
Container Closure Integrity Program
Leachables and Extractables
Environmental Monitoring

Partial Client List

Sanofi Pasteur
Glaxo Smith Kline
Glatt
Sanofi
Teva
McNeil
Johnson and Johnson