How We Serve

Start Up and Expansion Phase Companies

• Serve as Chief Medical Officer for executive team
• Prepare and/or review regulatory submissions, conduct audits or prepare for audits
• Conduct due diligence for the acquisition of new products and/or companies

Development Phase Companies

• Communicate with regulatory authorities
• Provide regulatory and clinical development services
• Review safety data

Marketed Product Phase Companies

• Medical and regulatory review of promotional materials (including labeling) to ensure compliance
• Provide pharmacovigilance services
• Design Phase IV studies

 

More Information

Dr. Carlson is an experienced senior executive with 20 years pharmaceutical industry experience in the development and post-marketing support of drugs, biologics, and diagnostics. She has proven ability to maximize opportunities to integrate scientific data and knowledge into effective and successful drug development and commercialization programs. Her in depth Clinical Development experience includes the design, initiation, medical monitoring and successful conduct of studies from phase 1 through 4.