Regulatory, Quality Assurance & CMC

From complex regulatory affairs topics 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 pre-ind through the products’ life cycle
  • Quality Risk Analysis for Products and Processes
Report Preparation

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 and reports to support patent litigation situations.

 

DevelopmentOperationsRegulatoryFormulation Development

Contact Us

RhoTau Pharma Services’ goal is to assist our clients, be they consumer product, generic or innovator firms, small start-ups or large, global pharmaceutical or biotechnology companies, with strategic and tactical implementation designed to rapidly bring their small or large molecule products to peak sales in order to fully realize their life cycle potential.

Other Services

Operations Support

Regulatory, Quality Assurance & CMC

Document Retention

Pharmaceutical Training