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Services

  • PIL READABILITY TESTING
  • SCIENTIFIC AND REGULATORY CONSULTING
  • PHARMACEUTICAL SPECIALISED TRANSLATIONS
  • PHARMACOVIGILANCE SERVICES
  • WRITING OF ALL MODULES OF AUTHORISATION DOSSIER
  • CTD AND eCTD SUBMISSION AND COORDINATION OF THE REGULATORY PROCEDURES
  • QUALIFIED PERSON ACTIVITY FOR BATCH RELEASE
  • QUALITY TESTING OF MEDICINES ON EEA TERITORY
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WRITING OF ALL MODULES OF AUTHORISATION DOSSIER

 

With our expertise in Chemistry, Pharmacy, Manufacturing, and Quality Control (QC) and medical/technical writing, we can assist you in preparation of Modules 1-5 of your CTD/eCTD dossiers.

 

Common Technical Documents are used to obtain Marketing Authorization across different nations. CTD format is now being adopted by many nations.

 

RUAL Farm adds value by:

Preparation of dossiers in CTD format for Marketing Authorization (MA) in various countries.

Re-formatting old Dossier/DMF to CTD format.

 

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