At our client’s request, we produce quality documents for regulatory affairs and those for medical (non-regulatory) affairs in a timely manner.

Regulatory Affairs:

• Protocols
• Clinical study reports
• Clinical pharmacology study reports
• New Drug Application sections
• Supplemental NDA sections
• Investigator Brochures and updates
• IND updates
• Patient safety narratives
• Consultation for drug development plans

Medical Affairs:

• Manuscript preparation for peer-reviewed journals
• Consulting services for new drug development plans, specifically cardiovascular, as well as other therapeutic areas
• Abstracts and posters for scientific meetings