Regulatory Affairs is in a way the bridge between the industry and the Competent Authorities/Ethics committees.
Whether your trial involves a drug, biologic, device or even a combination of them, we know the regulatory requirements and have the resources and expertise. Throughout the development stages, the companies must abide strict rules and guidelines in order to ensure safety and efficacy of the product in question.
CroxxMed regulatory staff navigates within cross-functional teams during the application process. We have extensive experience in advising, compiling, writing, and submitting applications and amendments to Competent Authorities as well as Ethics Committees.
Regulatory affairs services include:
- Consultation on legislation and country specific requirements
- Liaison with National Competent Authorities and Notified Bodies
- Applications for clinical trial authorization
- CE mark documentation and procedures
- Consultation for pharmaceutical and chemical documentation