Regulatory Compliance of Processes
PTS Consulting Global Services can provide assitance with Full FDA qualification and filing and managing the processes for FDA drug applications especially Abbreviated New Drug Applications (ANDAs), INDs (Investigational new drug) and 505(b)(2) NDA and BLA applications.
Thorough knowledge of pharmaceutical regulations in USA, Canada and European Union, Asia and other countries and is serving as US agent and adviser for numerous pharmaceutical companies firms located and/or operating in these regions.
PTS Global Services understands the critical importance of complete and accurate regulatory submissions and can collaborate on submission planning and preparation to ensure consistency, scientific accuracy, completeness, and regulatory compliance of all processes and documents and processes.
Compliance Problem Resolution
- Development, execution, monitoring and Regulatory Compliance of Processes Project Management
- Responding to an FDA 483 inspection or an FDA Warning Letter
- Consultation and direct communication with the FDA to resolve disputes
- Implementing corrective and preventive action (CAPA) programs
- Requiring the assistance of "a third-party role under a consent decree"