Birger Kintzel

Regulatory Affairs

CONELIS expert Birger Kintzel

Drug Regulatory Affairs Professional, Regulatory Affairs Services Dr. Kintzel

Berlin area

German, English, French, Russian

Services offered worldwide

www.kintzel-regulatory.com

Contact Me

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Offers

Drug Regulatory Affairs services, such as

  • Interim management
  • Contracting (home based or at client’s site)
  • Preparing and submitting CTAs and MAAs
  • RA lead function in development projects
  • Preparing Regulatory strategy documents
  • CMC dossier support and project transfer
  • Scientific Advice meetings incl. follow-up
  • RA Life-cycle work (variations, renewals, etc.)
  • Interface with BfArM, PEI, local authorities of supervision
  • Contact point to Rote Liste GmbH, Fachinfo-Service, ABDATA
  • Labelling (SmPC, Patient Leaflet, CCDS etc.)
  • RA in-house training to company staff
  • Due diligence meetings
  • Review of Ad/Prom documents

About Me

Industry positions held (1993-2008):

  • RA Manager at Janssen-Cilag GmbH
  • Head of RA at Synthelabo Arzneimittel GmbH
  • Head of RA at Pharmacia GmbH
  • Senior Director EU RA at Elan Pharma Ltd
  • Global RA Director at Baxter Healthcare

Freelance RA consultant since 2008
Independent Consultant at Parexel International since 2014
Regulatory Affairs Director at Cytolon AG since 2015

Qualifications

Diplom-Pharmazeut (PharmD)
Apotheker Approbation (Board certified pharmacist)
Dr.rer.nat. (PhD)

Education:

Studies of pharmacy at Ernst-Moritz-Arndt university of Greifswald (Germany)

Experience:

22 years experience in Regulatory Affairs (for details kindly refer to www.kintzel-regulatory.com)

Areas of Expertise:

Regulatory Affairs