Product-development evaluation
Our services in this area are:
Target product profile
- Market assessment
- Competitive environment
- Goal and degree of innovation
- Pharmaceutical aspects and key elements
- Medical evaluation of key drivers, trials and tests, pre-clinical aspects
- Registration strategy – regulatory positioning
- Pricing
- Life cycle management
Marketing summary
- Project idea
(differentiation potential – USP – market attractiveness and relevant countries) - Market and competition – worldwide overview
- Pricing
- Qualitative research data
Regulatory summary
- Registration strategy for key countries
- Dossier requirements
- Pharmacology toxicology summary
- Pharmacology and pharmacokinetics
- Pharmacokinetics profile – toxicology
Pharmaceutical development summary
- Drug substance and drug product
- Patent situation
Clinical summary
- Human safety
- Previous clinical experience
- Clinical development plan
Project plan
