Innovative Solutions: Regulatory and CMC Submission Consultancy and Support

The Tedor Pharma team members combine an extensive understanding of the regulatory approval process with an exemplary regulatory history to fully support your pharmaceutical development programs.

Regulatory Competencies:

  • CMC preparatory services for IND, NDA, ANDA, NDS, NADA,       ANADA, and MAA
  • Defined process for preparation and review of CMC
  • Early involvement in the submission process with
          cross-functional teams (Research and Development,       Analytical, Quality Control, and Regulatory)
  • Experience with - and regulatory knowledge of solid,
          semi-solid, liquid, aerosol, and inhaled drug products
  • Document preparation by persons directly involved in the       development and manufacturing processes.
  • Coordinated commitments to regulatory agencies with SOPs,       processes, and specifications
  • Documents prepared in a timely and efficient manner
  • Open and direct communication with customer's regulatory       department
  • SUPAC application support
  • GMP/FDA/ICH guidance
  • Product development strategies
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