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
With more than 20 years’ experience with these activities, we can provide you with unique service excellence. More detailed information and making a proposal?