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Product Application Support

Our experienced team of regulatory professionals dedicated to new projects will prepare and submit your project’s application on your behalf, or provide a package to you that is submission-ready. Regulatory staff are integrated into the R&D group to assure that the regulatory aspects are addressed throughout the product and analytical development stages.

Our regulatory team is accustomed to working with clients of all sizes, from small “virtual” companies to large, global organizations, and is capable of providing just the right level of support to complement your resources.

Services Offered:

  • Application Compilation and Submission in e-CTD Format
  • Regulatory Support for Interactions with Governing Agencies
  • Application Maintenance and Lifecycle Support
  • Act as Authorized U.S. Agent
  • Labeling support