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All services are provided with the utmost concern for high quality and customer expectations.  These services include, but are not limited to the following:

  • Regulatory Project Management
  • Preparation for and participation in regulatory agencies meetings
  • Strategic planning and risk assessment for CMC regulatory submissions
  • Document Preparation
    • Investigational New Drug (IND) Applications
    • Clinical Trial Applications (CTAs)
    • US New Drug Applications (NDAs)
    • US Abbreviated New Drug Applications (ANDA)
    • EU Marketing Authorization Applications (MAAs)
    • New Animal Drug Applications (NADAs)
    • Rest-of-World applications
    • Responses to Regulatory Agency inquiries

  • Comprehensive review of all types of CMC regulatory documents
  • Assistance in data analysis for establishing registration specifications

Don't see what you are looking for?  Contact us anyway and maybe we can help.  If we can't provide the services you need, we may know someone who can.

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