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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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SCIENTIFIC AND REGULATORY CONSULTING

 

RUAL Farm has the experience and expertise to provide all regulatory support services required for obtaining a Marketing Authorisation.

 

RUAL Farm staff offers expertise gained from over 18 years of combined service to the pharmaceutical industry. Our consultants specialize in providing an understanding of the regulatory and scientific issues relating to the testing and registration of medicines, dietary supplements, cosmetics and medical devices.

 

Our regulatory consulting group provides scientific and regulatory consulting services to clients for their generic drug research and development programs.

 

Our consulting team facilitates the planning and strategy of regulatory submissions so that reviews are completed in a manner that facilitates approvals.

 

Our team of specialists can provide in-depth consulting for regulatory submissions, as well as directly interface with the regulatory authorities for preparation and compilation of various submission dossiers and meeting packages.

 

Our development offer includes the pharmaceutical and analytical development of generic products. Besides the new applications, RUAL Farm's staff offers expertise in developing strategies and plans for answering authorities regulatory review questions on the application dossier, including conduct of experimentation to generate the required data for submission.

 

If anyone can make sure that the best possible medicines reach the patients without unnecessary delay – it’s RUAL Farm.

 

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