Certifications & Quality Assurance
Rigorous regulatory standards, cGMP validation, DRAP compliance, and 100% Halal certified softgel encapsulation.
Good Manufacturing Practice
GMP Certified
Our facility operates in full accordance with Good Manufacturing Practices, guaranteeing controlled cleanroom environments (ISO Class 7), strict sanitation protocols, automated encapsulation consistency, and complete batch traceability from raw material to finished product.
Key Verification Points:
- ISO Class 7 cleanroom encapsulation suites
- Automated gelatin ribbon thickness control
- Full batch validation and retention testing
Critical Control Points
HACCP Certified
Comprehensive Hazard Analysis and Critical Control Points (HACCP) management system deployed across all formulation, gelatin preparation, encapsulation, tumble drying, and packaging stations to eliminate biological, chemical, and physical contamination risks.
Key Verification Points:
- Continuous environmental and temperature monitoring
- Automated inline metal detection and visual sorting
- Stringent cross-contamination prevention barriers
Quality Management System
ISO 9001:2015
Internationally audited quality management frameworks covering customer requirements, vendor qualification, standardized operating procedures (SOPs), continuous process optimization, and exhaustive documentation for both domestic and global export clients.
Key Verification Points:
- Standardized chemical and microbiological SOPs
- Comprehensive vendor qualification protocols
- Annual third-party surveillance audits
Registered Facility
U.S. FDA Registered
Elate Pharma maintains an active U.S. Food and Drug Administration (FDA) facility registration, adhering to international nutraceutical safety standards, facility registration requirements, and export readiness for international brand partners.
Key Verification Points:
- Active FDA facility registration and FEI credentials
- Compliant labeling review for export territories
- Complete Certificate of Free Sale (CFS) assistance
Drug Regulatory Authority of Pakistan
DRAP Registered
Officially registered and licensed under the Drug Regulatory Authority of Pakistan (DRAP) for alternative medicines, nutraceutical products, and health supplements, ensuring total legal compliance and regulatory protection for private label brands.
Key Verification Points:
- Licensed under DRAP Alternative Medicines framework
- Form 7 and product enlistment documentation support
- Periodic federal regulatory inspection compliance
Product Confidence
100% Halal Certified
All gelatin utilized in our softgel encapsulation lines is 100% Halal-certified bovine bone gelatin sourced exclusively from certified suppliers, meeting strict Islamic dietary guidelines and verified by accredited Halal regulatory bodies.
Key Verification Points:
- 100% Halal bovine bone gelatin sourcing
- Complete absence of porcine or non-Halal derivatives
- Authentic batch-specific Halal Certificates issued
Need Batch CoA, Registration Copies or Export Dossiers?
We provide complete document packs for brand audits, institutional procurement, and export customs clearance. All technical dossiers are signed by our licensed QA/QC Pharmacists.