Dossier

Dossier

Reliable, CTD-Ready Files for Fast and Confident Product Registration

AGON supports pharmaceutical companies in sourcing and acquiring high-quality, CTD-ready product dossiers that meet regional and international regulatory requirements. Our end-to-end coordination ensures clients receive complete, compliant technical files for product registration, technology transfer, and portfolio expansion — without the uncertainties and delays associated with vendor screening and documentation gaps.

What We Deliver

CTD files Modules 1–5
Bioequivalence studies (as required by SFDA and regional authorities)
Stability data and supporting technical reports
Validation reports and GMP certificates
Full technical and regulatory documentation packages
Direct coordination with dossier suppliers and manufacturers

Contact

  • Building #10, Ground Floor, Business Park, Amman, Jordan
  • +962 (79) 1533337
  • m.abuzour@agonme.com

Brochures

Categories

We understand the importance of approaching each work integrally and believe in the power of simple.

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