Maraca International BVBA Regulatory Affairs

MARACA International can manage part of or your complete regulatory department activities.

This includes the development of or help with the development of:

• Regulatory strategy plan
• Regulatory guidances plan
• Regulatory literature review
• Regulatory design input
• Regulatory Performance evaluation plan
• Regulatory Performance evaluation report
• Essential requirements document
• STED Dossier
• Submission package with FDA
• Submission package with notified body
• Communication with FDA and other competent authorities
• Communication with notified body
• Registration of manufacturer with FDA and EU competent authorities
• Registration of products with FDA and EU competent authorities
• UDI development for products and manufacturer
• MDR reporting to competent authorities
• On-market surveillance of product
• On-market vigilance of product