Regulatory Affairs Services Dr. Kintzel
Serving the Pharmaceutical Industry since 2008

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
  • 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)
  • Information Officer as per § 74a AMG (German Drug Law) 
  • Acting on behalf of the client with BfArM, PEI, local authorities of supervision, Rote Liste GmbH, Fachinfo-Service, ABDATA
  • Review of Advertising/Promotion documents and ensuring regulatory compliance