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Regulatory Affairs

Regulatory Affairs

During the last years, there was rising demand in matters of registration and licensing of new products and / or maintenance of traditional licensed products. To deal with this increasing demand, we have expanded our department for registration services continuously.

Our support in regulatory affairs does not end with our classical analytical services and the generation of analytical results and figures.

Beyond that we offer services for the registration of human and veterinary drugs. Historically, GBA Pharma owns a special expertise in the approval of herbal preparations and homeopathic remedies.

Benefit from our experience. We offer:

  • General advice and support for approval of new products in human and veterinary medicine
  • Access to a long expertise in herbal and homeopathic remedies
  • Support for dossiers maintenance
  • Processing of complaints
  • Compilation and preparation of dossier documents in CTD format and NTA format
  • DMF (Drug Master File) Creation as ASMF, CMC, CEP
  • Consulting and support when organising "Scientific Advice" Meetings with the BfArM, AGES, AIFA, and Swiss Medic
  • Contact with the authorities
  • Discussion on all aspects of GACP (GOOD AGRICULTURAL PRACTICE AND COLLECTION)
  • Readability User Test

GBA PHARMA GMBH

SPECIAL SERVICES:

Folder "Regulatory Affairs"  download ›

Flyer "Variations"  download ›