About us
Simplifying Compliance, Amplifying Quality
Quality Edge Pharma is an expert pharma consultancy ensuring compliance, quality, and operational excellence globally.
Your Trusted Partner in Pharmaceutical Excellence!
Quality Edge Pharma, we are dedicated to empowering pharmaceutical companies by offering comprehensive consultancy services designed to enhance quality, compliance, and operational excellence. With a foundation built on over 20 years of industry experience, our firm provides an unparalleled level of expertise, commitment, and results-driven solutions to meet the evolving challenges of the pharmaceutical sector.
Services
Quality Edge Pharma Quality Services
We offer regulatory compliance, cGMP consulting, validation, 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
