CMC & Manufacturing Compliance

We offer a comprehensive range of services, including:

Gap analysis and remediation
Preparation of CTD modules 2 and 3
DMF preparation
QP services
Import documentation and licensing
GLP/GMP audit
Pre approval inspections
Batch release and analytical testing for batches
Warehousing

Case studies

Discover how our services work in action.

CMC and Manufacturing Compliance

This leading global life sciences organization maintains GMP standards by outsourcing supplier audits to elc group

CMC and Manufacturing Compliance

elc group helps this leading pharma company pass its FDA inspection with flying colors