Service
Quality Edge Pharma Quality Services
We offer Third party Audits, cGMP consulting, Regulatory Audit compliance, Regulatory filings, Product Development, Trainings, Validations, Qualifications, Market research and IT solutions for pharmaceutical excellence.
New Product Development and Technology Transfer
- Product Development, Scale up and Technology Transfer
- Process optimization & Trouble shooting
IT Services & Support
- Development of Customized soft wares as customer needed
- eQMS implementation and support
- 21 CFR compliance verification & support for software systems updations.
Regulatory Filings & Support
- CEP Fillings
- DMF Preparation and NDA/ANDA Submissions
- Country-Specific Regulatory Guidance
- Regulatory Agency Coordination and Submission Tracking
- Difficencies Response
Analytical Services
- Customers samples testing & Reporting the Results
- Method Development and Validation
- Stability Studies and Testing
- Microbial Testing and Environmental Monitoring
- Nitrsoamine, Genotoxic & Elemental impurities evolution & Testing
Validation & Qualification
- Process Validation
- Cleaning Validations
- Equipment Qualifications
- HVAC and Major Utilities Qualification
- Computer system validations
- Development of Validation Master Plan & Protocols
cGMP Consulting Services
- Gap Analysis & Remediation
- SOP Management
- Employee Trainings
- On site Audit support
- Risk Management
- QMS Enhancement
Audit & Compliance
- Regulatory Audit Preparation
- Third-Party Audits
- CAPA Compliance
- Vendor & Supplier Audits
Market Research
- Market Analysis and Feasibility Studies
- Competitor Bench marking and Pricing
- Supplier Sourcing and Procurement Assistance
- Sales Strategy and Distributor Network Development
Additional Services & Support
- Temperature mapping for storage areas and Clean rooms along with Protocols and Reports
- Instruments Calibrations and Certification
- New Facility Design and Support
