Regulatory

SANTA S.A. provides regulatory and documental support for pharmaceutical and nutraceutical products developed and/or manufactured at our premises.

Documentation

Pharmaceutical Products

  •  CTD format, in accordance with  Notice to Applicants – volume 2B
  • e-CTD format also available if requested
  • in accordance with ICH and EMEA guidelines
 

Food Supplements

  • Product Technical Documentation containing information regarding composition, manufacturing process, analyses and regulatory information useful for the label of the finished product.

Our Regulatory Affairs department collaborates also with external experts for the redaction of the clinical modules.  

Certifications

  • EU GMP Certificate issued by the Romanian Medicines Agency (ANMDM)
  • Authorized by the Romanian Authorities to produce pharmaceuticals and food supplements

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