We provide end-to-end documentation and compliance services, including:
Quality Management System (QMS) Documentation
- SOP Preparation
- Master Documents
- Quality Manual
- Training Manual
- HR Manual
- Safety Manual
- Site Master File (SMF)
- Validation Master Plan (VMP)
- Risk Assessment Documents
- Deviation, CAPA, Change Control formats
Validation Services
- Equipment Qualification (IQ, OQ, PQ)
- Process Validation
- Cleaning Validation
- Computer System Validation (CSV)
- ERP Validation Documentation
- PLC / SCADA Validation
Regulatory Documentation
- CTD / eCTD Dossier Preparation
- Module 1–5 Documentation
- Product Registration Dossiers
- ANDA / DMF Support
- Regulatory Gap Analysis
Audit & Compliance Support
- Internal Audit Documentation
- Vendor Audit Support
- Regulatory Inspection Preparation
- Mock Audit Services
Technical Documentation
- URS, FRS, DS Documents
- SOP for Manufacturing & QC
- Protocol & Report Writing
- Qualification & Validation Formats