Our Experience
Over 30 years of experience in pharmaceutical and biopharmaceutical industry with on-going involvement in compliance and quality systems. Extensive background in Gap/Risk Analysis, Baseline Audit of (Internal and CMO). Comprehensive review of the Quality Standards, along with Design for Six Sigma Activities, Software Validation, Aseptic/Fill Finish Qualification, Cycle development (CIP, autoclave), Optical Recognition Firmware, SAP, SOP generation and training, Validation project management.
- Harmonization of global standards with local SOPs and procedures in compliance with 21 CFR Part 11 and six major quality systems.
- Site audits and gap assessments of SOPs and technical documentation related to electronic records and signatures (ER/ES), data integrity, and system classification.
- Data Integrity & System Controls
- Computer System Validation (CSV) and Part 11 Compliance
- Qualified PLC-based systems
- Validated Quality Control equipment
- Infrastructure & Project Management
- Audit Readiness & Supplier Management
- Cross Contamination and Quality Improvement Plan (QIP)
- Fill Finish/Aseptic Qualification
- Facilities, Utilities and Equipment Qualification
- QA on the floor oversight
- Cleaning Validation
- Sterility Assurance
Our Approach
Our service focuses on having a holistic approach to the entire organization while treating each quality system as part of the synergetic unit rather than performing tasks in silos. Having a comprehensive understanding of intradepartmental and interdepartmental dynamic allows us to complete deliverables in the most efficient manner while maintaining COMPLIANCE with INTEGRITY.
Why Us?
Having such diversified experience in areas of Compliance oversight, Validation Project Management, GAP analysis makes us one stop for all Compliance and Validation needs.