Your partner in ensuring a successful drug-device combination product launch
Combination product requirements
Important differences exist in the US and European regulation of drug-device combination products and drug delivery devices. Donawa Lifescience Consulting (DLC) helps companies understand these differences so that project milestones can be more efficiently reached within planned timelines.
US regulatory and quality system requirements
DLC provides the support you need to understand and properly interpret US regulatory and clinical data requirements and "grey" areas and anticipate FDA expectations, which is fundamental for the success of combination products destined for the US. Our recognized expertise in US medical device quality system implementation and compliance means DLC can also help you to address quality system requirements for these types of projects.
EU regulatory and quality system requirements
DLC can help you formulate effective European regulatory and quality system strategies for the device components of combination products, and if requested, provide feedback and support regarding the drug component.
EU and US clinical study management
DLC is uniquely qualified to be your partner in managing and monitoring your clinical study sites throughout the EU, US and Canada.
DLC has the knowledge and experience to assist you in the development of effective regulatory, clinical study, and quality system strategies, so that important project milestones within planned timelines can be met. Contact us either by e-mail for a confidential discussion about your project, or call Dr. Maria Donawa, President, on +39 06 578 2665.