EU/US Combination Product Services
 
 
Your partner in ensuring successful compliance with drug-device combination product requirements
 
Combination product requirements
 
Important differences exist for US and European requirements for drug-device combination products and drug delivery devices. Gemar helps companies understand these differences so that project milestones can be more efficiently reached.
 
 
EU regulatory and quality system requirements
 
Gemar can help you formulate effective regulatory and quality system strategies for the device components of combination products, and if requested, provide feedback and support with regard to the drug component as well.
 
 
US regulatory and quality system requirements
 
Gemar provides the support you need to understand and properly interpret US requirements and "grey" areas and anticipate FDA expectations, which is fundamental for the success of combination products destined for the US.
 
 
EU and US clinical study management
 
Gemar is uniquely qualified to be your partner managing and monitoring your clinical study sites throughout the EU and in the US. 
 
 
GEMAR has the knowledge and experience to assist in the development of effective regulatory, clinical study, and quality system strategies, so that important project milestones can be met. Contact us either by e-mail for a confidential discussion about your project.