PHARMWRITE™

Why PharmWrite™?
PharmWrite™ is a suite of Common Technical Documents templates for the development of submission content.

Regulatory professionals use PharmWrite™ to:

• proactively identify data and information requirements
• facilitate decisions on key content inclusion
• reduce regulatory risk

 
Features include:

• More than 80 separate document templates tailored for any product formulation
• FDA Guidance Interpretation and ICH Guidelines
• Risk-based evaluation elements
• Special emphasis on the Quality Overall Summary (QOS), Module 2 and 3 Quality sections of the CTD submission.
• Boiler Plate content, sample narratives, table shells and instruction on data presentation and conclusions
• Automation of frequently used authoring tools.

 
Tailored for any stage of drug development, PharmWrite™ provides a forward-looking view of the natural growth of the Quality sections of an IND application as product knowledge throughout the drug development life cycle.