Kontakt
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