Experts

Fischer, Bernhard

Prof. Dr.

Kontakt

Biotechnology Consulting

Postfach 39
1150 Wien

b.fischer@apeptico.com

http://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