SML LAB

Our Services

GMP Audit

Pre-regulatory inspections (WHO, USFDA, MHRA, EU GMP)
GAP analysis in existing QMS
Pre-certification inspections (ISO, FSMS, NSF)

GMP Training

Good Manufacturing Practices
Good Laboratory Practices
ISO Documentation
Process & Analytical Method Validation

Quality Management System

Quality Assurance System
Production System
Laboratory Control System
Material & Packaging Control System

Formulation Development

Pre-formulation & compatibility studies
Lab & pilot scale validation
Stability studies
Analytical method development

Custom Synthesis

API & KSM development
Reference standards & impurity characterization
DMF / ANDA compilation
Regulatory query response support

Pharma Innovation & Analytical Solutions

We provide comprehensive pharmaceutical solutions including API impurities, API intermediates, nitrosamine impurities, CRO & CDMO services and advanced analytical support.

Pharma Products, Analytical Services and Consulting

Pharma Products & Consulting

Our capabilities include pharmaceutical products and intermediates, analytical testing, method development and validation, and pharma consulting and QA/QC support.