Pharmaceutical Validation
The global pharmaceutical industry is under pressure to reduce drug development cycle time and to meet increasingly tight regulatory compliance requirements in the US, Europe, and developing markets.
We provide comprehensive end-to-end solution for client’s Pharmacogenomics, Pharmacovigilance, Bio Informatics and laboratory informatics (LIMS) requirements. Leveraging almost 10 years of consulting experience in the Life Sciences industry, we provide customized technology and services solutions. Working as a strategic business partner, we enable clients to revolutionize their Life Sciences function.
Our team of experts includes seasoned Validation Engineers, Technical Writers, pharmacists, Lab Techncians and healthcare specialists. We work closely with regulatory authorities across the world in the drug safety area. We are committed to optimize spend and staffing on quality and safety activities through continuous improvement-oriented service delivery model.
Our teams are well qualified in industry best practices for validation, qualification, compliance assessments, and vendor audits that cover systems and processes in all your regulated areas.
VALIDATION SERVICES
- Computer System Validation
- Equipment Validation
- Utility Validation
- Clean Room Validation
- Cleaning Validation
- Manufacturing Validation
- Analytical Instrument Validation
- Process Validation
- Commissioning / Decommissioning
TECHNICAL EXPERTISE
- GxP Assessments
- Validation Master Plans
- Validation Risk Assessment
- URS Generation
- FRS Generation
- IQ/OQ/PQ Protocols
- Validation Reports and
- SOP Development
- Internal Auditing
COMPLIANCE STANDARDS
- 21 CFR Part 11
- 21 CFR Part 50
- 21 CFR Part 56
- 21 CFR Part 58
- 21 CFR Part 210
- 21 CFR Part 211
- 21 CFR Part 820
CLINICAL AND LABORATORY SYSTEMS
- Pharmacovigilance System
- Clinical Trial Management System
- Laboratory Information Management System
- Submission Management
- Pharmacogenomics
- EDMS
- Clinical Data Management System
- Safety Reports
- Adverse Event Reporting System