Pharma Document Preparation
We provide complete documentation support tailored to your product type (tablets, injectables, APIs) and target markets (EU, US).
Our Services Include:
- Writing documents from scratch
- Reviewing and improving existing SOPs
- Ensuring regulatory compliance (WHO, US FDA, EMA and ANVISA)
- Audit and inspection preparation
We can build your entire QMS from the ground up.
1. Quality Management System (QMS) Documents
The foundation of GMP compliance:
- Quality Manual
- Quality Policy
- Site Master File (SMF)
- Validation Master Plan (VMP)
2. SOPs (Standard Operating Procedures)
Essential operational documents:
- Equipment Cleaning SOP
- Batch Manufacturing SOP
- Deviation Handling SOP
- Change Control SOP
- CAPA SOP
- Complaint Handling SOP
3. Production & Batch Documents
The foundation of GMP compliance:
- Batch Manufacturing Record (BMR)
- Batch Packaging Record (BPR)
- Master Formula Record (MFR)
- Equipment & Temperature Logbooks
4. Quality Control (QC) Documents
- Product & Raw Material Specifications
- Analytical Methods
- Method Validation Reports
- Stability Study Protocols & Reports
- Certificate of Analysis (CoA)
5. Regulatory & Compliance Documents
- Dossier Preparation (CTD / eCTD)
- GMP Audit Reports
- Risk Assessments (ICH Q9)
- Data Integrity Documentation
6. Training & Personnel Documents
- Training SOPs
- Training Records
- Job Descriptions
- Qualification Matrix
7. Facility & Engineering Documents
- HVAC Qualification Documents
- Water System Validation
- Environmental Monitoring Procedures
- Calibration Records