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Regulatory Affairs

The drug regulatory affairs fairs group offers regulatory services for human and veterinarian medicinal products such as new active ingredients, generics, herbal medicinal products and biotech products.

  • » Advice on regulatory requirements and application strategies
  • » Negotiations with the authorities
  • » Preparation of all parts of a registration dossier
  • » Compilation of registration dossiers in any format, especially as common technical document (CTD)
  • » Follow-up of submitted documentation
  • » Dealing with deficiency lists and variations
  • » Preparation of drug master files
  • » Applications of certificates of suitability
  • » Allergenicity and photosensitization tests on topical dosage forms.
  • » Expert opinions and reviews, especially for regulatory compliance
  • » Medical Writing.

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