Assembling the Words That
Bring Meaning to Your Work

ClinSmart is highly knowledgeable when it comes to preparing regulatory documents to support drugs, biologicals, and devices submissions to regulatory agencies. We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements for different regulatory agencies.

We create multiple documents to fit your multiple needs:

• Investigator Brochures  

• Protocols, Charters, and Informed Consents  

• Clinical Trial Reports  

• Scientific posters and papers  

• Clinical manuscripts to support marketing and journal publications 

• All NDA section summaries