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.

Our Expertise

• 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