Fach-Experten

Fischer, Bernhard

Prof. Dr.

Kontakt

Biotechnology Consulting

Postfach 39
1150 Wien

b.fischer@apeptico.com

www.apeptico.com

Fachgebiet / Branche

  • Beratung / Consulting / Dienstleistung
  • Biotechnologie / Life Science
  • Chemie
  • Gesundheit / Medizin
  • Umwelt / Nachhaltigkeit

Spezialisierung

  • Controlling
  • Geschäftsmodellentwicklung
  • Organisation
  • Projektmanagement
  • Prozess-, Qualitätsmanagement

Beschreibung

I offer following services in biotechnology and biomedicine:

  • Regulatory affairs management of the drug development process
  • Planning and performance of all preclinical and clinical activities
  • Toxicity, safety pharmacology & stability studies
  • Pharmaceutical formulation development
  • Analytical, specification & release testing development
  • Quality management GLP & GMP
  • Manufacturing process development at various scale
  • Drug development documentation, IMPD, IND & CTA
  • Project management & direct costumer support
  • Sourcing of venture capital and financial support
  • Management of scientific advice meetings and orphan drug application
  • SME declaration and contact to medicinal agencies