Quality Support
We design robust quality management systems according to our client’s needs. We offer a full range of services in GLP, GCP, and GMP compliance from development through commercialization. Our prime quality related services are.
- Quality Lifecycle Management
- Quality Systems & Operations
- QMS designing and Technical Writing
- GxP Auditing & Gap Assessment
- GxP Regulatory Inspection Support & Trainings
We help during quality operations
Step1
Quality Lifecycle Management
- Technology Transfer
- Manufacturing scale up and Exhibit batches
- GMP and non-GMP batches
- Post-approval management
Step2
Quality Systems & Operations
- US FDA-GMP, GLP, and GCP
- Health Canada-GMP, and GLP
- EU-GMP, and GLP
Step3
QMS designing and Technical Writing
- Site master file
- Master validation plan
- Computer System Validations (CSVs)
- Site qualifications
- Instrument qualifications
- Process validations
- Cleaning validations
Step4
GxP auditing & Gap assessment
- GLP-OECD, 21 CFR Part 58
- GMP-21 CFR Part 210 & 211
- GUI-0001 & GUI-0104
- EU-GMP
- GCP-ICH
Step6
GxP Regulatory inspections support & trainings
- Vendor qualifications
- FDA Inspections
- Health Canada
- Standard council of Canada
- ISO-9001 / 17025 / 13485
Step7
Remote QA support
- GMP operations
- GLP operations
- GCP operations