Regulatory Affairs Services 
Dr. Birger Kintzel 

Here is a selection of Regulatory services that I am offering to you:  

  • Contracting – home based or at client’s site
  • Interim management roles
  • Preparing and submitting CTAs and MAAs
  • RA lead function in regional / global development projects
  • Preparing Regulatory Strategy documents and leading Scientific Advice meetings with Regulatory authorities
  • Regulatory maintenance work (variations, line extensions, renewals, PSURs) for Austria, Germany and Switzerland incl. document portal upload to PharmNet.Bund (BfArM), eServices (BASG-AGES) and eGOV (Swissmedic) 
  • CMC support incl. dossier writing (Quality Overall Summary, Module 3, Drug Master Files, variation packages etc. ) and project transfer 
  • Labelling tasks incl. alignment of Product Information with Core Company Data Sheets
  • Due Diligence tasks in the context of product or project acquisition
  • Supporting clients during company set-up in Germany (e.g., applying for wholesale, import, export, controlled drug and manufacturing licences, PNR, PZN, FML serialization features)
  • Information Officer as per § 74a AMG (German Drug Law) 
  • Acting on behalf of the client with BfArM, PEI, German local authorities of supervision, Rote Liste GmbH, Fachinfo-Service, ABDATA, IfA GmbH, SecurPharm/PharmaProtect, AMVS, GS1, BASG-AGES,  Apothekenverlag/Warenverzeichnis, Arge Pharma, Swissmedic, HCI Solutions
  • Preparing and submitting additional Risk Minimization Material (aRMM) to BfArM, PEI and BASG-AGES
  • Preparing and submitting "barrier-free" PILs in PDF_UA format (Austria)
  • Review of Advertising/Promotion documents and ensuring regulatory compliance