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Quality Management System (QMS) Services
Quality Management System (QMS) Services
Ensuring Compliance & Continuous Improvement for Pharma, Biotech, & Medical Device Manufacturers
A Quality Management System (QMS) is the foundation for pharmaceutical, biotech, and medical device companies to maintain compliance with regulatory standards while ensuring product quality and operational efficiency.
Our QMS services help businesses design, implement, and optimize their quality systems to meet regulatory, customer, and business requirements.
Why Choose Isha’s GMP for QMS?
- Expert Guidance on Regulatory Compliance
- ICH Q10-based Integrated QMS Approach
- Custom-Tailored, Cost-Effective Solutions
- Scalable & Sustainable QMS Programs
Our Comprehensive QMS Services Include:
QMS Development & Implementation
- Establishing a new QMS or redesigning an existing QMS
- Implementing Quality Risk Management (QRM) principles
- Aligning QMS with FDA, MHRA, EMA, and ICH Q10 guidelines
Documentation & Process Control
- SOPs, Batch Records, Protocols (Validation, Qualification, Stability, etc.)
- Master Batch Record & Production Batch Record Review
- Label Control & Documentation Compliance
Audits & Inspections
- Conducting internal and external audits
- Preparing for regulatory inspections (FDA, EMA, MHRA, etc.)
- Post-audit support & remediation
Quality Assurance & CAPA Management
- Handling OOS, deviations, and investigations
- CAPA (Corrective & Preventive Actions) program management
- Supplier Quality Management & Risk-Based Audits
Product Lifecycle & Compliance Oversight
- Production & Warehouse Quality Control
- Supply Chain & Computer System Validation
- Product Release & Customer Complaint Handling
Drive Compliance & Operational Excellence with Isha’s GMP!
We provide tailored QMS solutions that reduce risks, enhance compliance, and improve product quality—all within a time-efficient and cost-effective framework.
Need QMS Support? Contact Isha’s GMP Today!