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Products

Active Pharmaceutical Ingredients

Bulk Drug Intermediates


Services

Outsourcing Service

Pharmaceutical Formulations



Products Services Company Profile Clientele Formulation Development

Dossier Compilation

Home • Dossier Compilation

Dossier Compilation

We compile dossier according to the requirements of the regulatory authority and the markets.

  • Compilation of the dossiers according to CTD-format 1-5 including handling of deficiency letters

  • Compilation of e-CTD

  • Compilation of US ANDA

  • Co-ordination of translations

  • Co-ordination of clinical and pharmacological-toxicological expert reports
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  • Co-ordination of clinical studies for bioavailability
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