Pharmacovigilance and Regulatory Documentation
We prepare and critically review a broad range of pharmacovigilance, clinical safety and regulatory documents, including:
- Signal evaluation reports
- Risk Management Plans
- PSURs and PBRERs
- DSURs
- Investigator’s Brochures
- Development Core Safety Information and Reference Safety Information
- Clinical study protocols
- Informed consent forms
- Safety monitoring plans
- Statistical analysis plans
- Clinical study reports
- Integrated safety analyses
- Regulatory authority responses
- Safety sections of submission dossiers
- Prescribing information and product labelling
- Dear Investigator Letters
- Direct Healthcare Professional Communications
- Risk-minimisation and educational materials
We ensure that safety data, emerging risks and benefit–risk conclusions are represented accurately and consistently across clinical, pharmacovigilance and regulatory documentation.