Pharma

The founders have a background of either MD or DVM and have spent more than 20 years in pharmaceutical industry, fulfilling a broad range of functions such as:

Medical director, Head of pre-clinical research, Head of in-licensing.

Our main therapeutic area expertise include:

• Cardiovascular
• Hemostasis & thrombosis
• Pain
• Gastroenterology
• Metabolic diseases
• Dermatology
• Urology

We have close working relationships with additional experts and key opinion leaders in the clinical community who are available on a project basis, as needed.

Established Products

CapDelta Group has for several years provided services within regulatory documentation on established products:

• Clinical overviews
• Non-clinical overviews
• Clinical expert reports
• Non-clinical experts reports
• PSURs
• Response to PRAC questions
• SmPC updates

Pre-Launch & Launch Activities

CapDelta Group has significant business development insight enabling complete strategic assessments, analysis and guidance in regard to business decisions.

We help clients define the market opportunity, assess the potential, and develop strategies including tactics to achieve the goals:

• Product & Market Opportunity Assessment
• Medical briefing documents
• Basic literature searches
• Documentation for product USPs
• Corporate and marketing presentations
• Competitive analysis
• Clinical strategy plan
• Regulatory requirements
• Publication plan
• Sales & Customer Training Program Development & Implementation
• General SWOT Analysis & Recommendations
• Scientific proof reading: Commercial material, PR material, scientific material
• Physician Advisory Board Development
• Key opinion leader identification and contact

Preclinical Research and Development

CapDelta Group comprises expertise in the pre-clinical areas of pharmaceutical research and development within the areas of pharmacology, toxicology, kinetics and ADME, as well as knowledge and experience in set-up and facilitation assessments, analysis and guidance within the following pre-clinical disciplines:

• New Biological Entities
• New Chemical Entities
• Endpoints
• Study design
• Study monitoring
• Data interpretation
• Project management
• Regulatory requirements
• GLP-regulated activities
• Document preparation
• Authority interaction