Scientific Writing
We help with drafting, reviewing, updating or full writing of the following scientific documents:
- Pharmaceutical Development Reports
- Quality Overall Summary (QOS)
- Quality Information Summary (QIS)
- API Comparative Reports
- Comparative Batch Analysis Reports
- Comparative Dissolution Reports
- Process validation protocols and reports
- Justification in support of variations
- Bioequivalence Trial Information Form (BTIF)
- Stability protocols and reports
Clinical Writing
We help with drafting, reviewing, updating or full writing of the following clinical documents:
- Labeling (SmPC, leaflets and labels)
- Clinical study protocols
- Informed consent forms
- Clinical study reports
- Bioanalytical study reports
QA Writing
We help with drafting, reviewing, updating or full writing of the following QA documents:
- Master documentation
- Annual Product Quality Review(s)
- Standard Operating Procedures