Medical Affairs

psn provides a professional consulting service by senior executive experts from the pharma and biotech industries. For many years, psn has maintained agreements with a comprehensive panel of well-recognized experts that work cross-functionally on several disciplines and therapeutic areas:

• Drug development programs
• Medical assessments and information
• Evaluation of in-licensing and acquisition opportunities
• Clinical development assessments and plans
• Pre-clinical development assessments and plans
• Regulatory strategies, procedures, assessments and plans
• Pharmaceutical development and quality both small molecules and protein

Share with us your challenges and we will study the alternative options!

psn can offer assistance with medical writing throughout Europe and the US. All reports are prepared in strict accordance with US/EU/ICH guidelines and regulations.

A few examples include:

• Protocol design/review and amendments
• CRF design and preparation
• Clinical study reports
• Statistical reports
• Integrated summaries of safety and efficacy
• Patient informed consent
• Patient diaries
• Key opinion leader reports
• Investigator brochures
• Medical texts for package leaflets
• Scientific articles

Documents may be prepared in multitude of languages.