Quality
Quality Assurance (QA)
Data Integrity & Documentation
Quality Assurance (QA)
- Implementation of GMP & cGMP systems
- Preparation & review of SOPs, BMRs, validation protocols
- Internal audits & inspection readiness
- Change control, deviation, and CAPA management
- Vendor qualification & third-party audit support
Quality Control (QC)
Data Integrity & Documentation
Quality Assurance (QA)
- Calibration & qualification of instruments
Data Integrity & Documentation
Data Integrity & Documentation
Regulatory & Compliance Quality
- Compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)
- Secure & compliant electronic records (21 CFR Part 11)
- Batch record review & release processes
- Document lifecycle management
Regulatory & Compliance Quality
Regulatory & Compliance Quality
Regulatory & Compliance Quality
- Audit support for WHO, USFDA, EU-GMP, CDSCO inspections
- Gap analysis & compliance risk assessments
- Technical dossier & regulatory submission support
- Serialization & traceability compliance
Training & Capacity Building
Regulatory & Compliance Quality
Training & Capacity Building
- Training programs on GMP, GDP, GLP, and QMS
- Mock audits & inspection handling workshops
- Continuous learning for quality culture improvement
Why Choose Us for Quality?
- End-to-End Solutions – Covering RM, PM, facility, production, QA/QC, and regulatory compliance
- Global Standards – Based on WHO, USFDA, EMA, ICH, ISO guidelines
- Experienced Team – Backed by 20+ years of pharmaceutical industry expertise
- Risk Reduction – Proactive identification of gaps before regulatory inspections
- Sustainable Compliance – Building a culture of continuous improvement
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