Our Commitment
Quality is Non-Negotiable
Every product we export undergoes multiple layers of quality verification. We partner exclusively with certified manufacturers and implement our own quality checkpoints at every stage.
Our Process
6-Layer Quality Process
Every batch, every shipment — no exceptions.
Manufacturer Verification
Before onboarding any manufacturing partner, we verify WHO-GMP certification, conduct facility audits (virtual or in-person), check regulatory history, and assess production capacity.
Raw Material Sourcing Oversight
We ensure manufacturers source APIs and excipients from approved, tested suppliers with valid COAs — verified at the source, not just at the end of production.
In-Process Quality Checks
During production, manufacturers follow SOPs with in-process controls at every stage — blending, granulation, compression, coating, filling, and packaging.
Finished Product Testing
Every batch tested for identity, potency, purity, dissolution, disintegration, microbial limits, heavy metals, and stability in NABL-accredited labs.
Pre-Shipment Inspection
Final verification before dispatch — correct labeling, packaging integrity, documentation completeness, and cold chain compliance where required.
Batch Traceability
Every product shipped is fully traceable — from raw material source to finished product delivery — with complete documentation maintained for audit readiness.
Certifications
Compliance at Every Level
ScaleMitra Health — Company Certifications
IEC — Import Export Code (DGFT)
Registered with Directorate General of Foreign Trade
Drug License
Issued by State Drug Controller
GST Registration
Goods and Services Tax registered entity
FSSAI License
Application in progress
Pharmexcil Membership
Application in progress
Our Manufacturing Partners Hold
WHO-GMP
Global Manufacturing Standard
ISO 9001:2015
Quality Management System
USFDA
Registered Facilities
EU-GMP
European Compliance
MHRA UK
British Market Approved
TGA Australia
Australian Compliant
NABL Labs
Accredited Testing Labs
HALAL & KOSHER
Available on Request
Have Specific Quality Requirements?
Tell us your target market and certification needs — we'll match you with the right manufacturing partner and provide complete documentation.