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

Quality Lifecycle Management

• Technology Transfer
• Manufacturing scale up and Exhibit batches
• GMP and non-GMP batches
• Post-approval management

GxP auditing & Gap assessment

• GLP-OECD, 21 CFR Part 58
• GMP-21 CFR Part 210 & 211
• GUI-0001 & GUI-0104
• EU-GMP
• GCP-ICH

Quality Systems & Operations

• US FDA-GMP, GLP, and GCP
• Health Canada-GMP, and GLP
• EU-GMP, and GLP

GxP Regulatory inspections support & trainings

• Vendor qualifications
• FDA Inspections
• Health Canada
• Standard council of Canada
• ISO-9001 / 17025 / 13485

QMS designing and Technical Writing

• Site master file
• Master validation plan
• Computer System Validations (CSVs)
• Site qualifications
• Instrument qualifications
• Process validations
• Cleaning validations

Remote QA support

• GMP operations
• GLP operations
• GCP operations