Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Comprehensive Active Pharmaceutical Ingredient (API) documentation and Drug Master File (DMF) management are critical for successful product registration and manufacturing authorization. Globaxa provides expert support in preparing, submitting, and maintaining API documentation across global regulatory authorities.
API Documentation Services
Complete API Documentation Package
- Comprehensive API characterization
- Manufacturing process documentation
- Quality control specifications
- Analytical method validation
- Impurity profile and qualification
- Reference standards documentation
- Stability data compilation
- Batch analysis records
Manufacturing Site Documentation
- Site Master File preparation
- Manufacturing process flow diagrams
- Equipment descriptions and qualifications
- Process validation protocols and reports
- Cleaning validation documentation
- Quality management system overview
- Environmental monitoring procedures
Quality & Control Documentation
- Specifications for starting materials
- In-process control specifications
- Finished API specifications
- Analytical procedures with validation
- Certificate of Analysis format
- Stability protocols and data
- Impurity qualification studies
- Polymorphic form characterization