Regulatory Medical Writing
We can write high-quality, time-sensitive comprehensive and scientifically-accurate documents to meet strict regulatory deadlines with an extensive knowledge of Health Authority Guidelines.
- Product Circulars, Summary of Product Characteristics
- Pharmacovigilance Documents
- Advisory Committee Briefing Packages
- INDs and IND Amendments
- Clinical Protocols and Amendments
- Regulatory Agency Briefing Documents
- Nonclinical or Clinical Interim Data Summaries
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