Marianne performs business development and project management assignments. For the latter, a virtual project group is often established, including other consultants and contract research organizations, with outsourcing of laboratory work, manufacturing of API and clinical trial material.
Marianne has extensive experience with development of drug delivery systems/vehicles for drugs with low water-solubility for preclinical or clinical use.
Business development
- Project development plans
- Project evaluations (due diligence)
- Business plans
- IPR management
Outsourcing
Outsourcing of preclinical studies, preformulation studies, drug substance and drug product development, GMP manufacture of API and clinical trial material.
Project management
Project management of early-stage drug development and clinical trial applications including coordination of:
- Preformulation work
- Preclinical safety and toxicological studies
- Formulation development (parenteral, topical, inhalation, oral preparations)
- Drug substance and drug product manufacturing for clinical trial
- Clinical study protocol development
- Documentation for CTA application
Also discrete project activities e.g. planning of preclinical studies and drug product development work are performed.