From complex regulatory affairs issues to multinational CMC submissions, RhoTau Pharma Services expertise will quickly identify development, manufacturing or stability issues that could impact product registration.
Regulatory, Quality Assurance and CMC Support:
- Due Diligence for Compounds, Products , Process and Supply Chain
- Expert Advice from Submission through Pre-Approval Inspection
- Quality Risk Analysis for Products and Processes
Throughout the development lifecycle, you will need to prepare comprehensive reports to support research and development needs, regulatory submissions, and product registrations, e.g. CMC documentation for INDs/IMPDs, NDAs/MAAs, and sNDAs/Variations. Working collaboratively with your staff, RhoTau’s years of technical experience will help create the necessary documentation with the right commentary and analysis to meet your internal and Health Authority requirements.
Intellectual Property, Patents
As a situation may arise during development or after commercialization, we can provide technical expertise and expert witness testimony to support patent litigation situations.