Our Services Cover:
GMP Compliance for Intermediates:
Implementation of ICH Q7-compliant practices
Controlled environment and process documentation
Quality risk management and deviation handling
Validation & Qualification Support:
Process validation for intermediate stages
Cleaning validation of equipment and production lines
Analytical method validation for in-process testing
Documentation & Quality Systems:
Batch Manufacturing Records (BMR) and logbooks
Change control, CAPA, and deviation management
SOP development and lifecycle maintenance
Regulatory & Supply Chain Readiness:
DMF/CTD documentation support for regulated intermediates
Vendor and raw material qualification
Audit preparedness and gap assessments