We offer a comprehensive service portfolio covering all stages of pharmaceutical development:
- Interim Management
- Regulatory Interactions
- Designated Sponsor
Translational project management from the laboratory bench to clinical development.
VPM offers services in the areas of project planning and management including our reverse-planning approach, validation, budgeting and risk analysis (gap analysis, red flag analysis). With our experience and network consisting of CMOs, CROs and academic research centres, we identify and manage the optimal development path for your product.
VPM valuates and evaluates projects and supports due diligence processes considering science, technology and development potential as well as financial and marketing aspects, e.g. market analyses and rNPV calculations.
Our experts provide operational, scientific and regulatory advice and facilitate the interaction with international authorities, e.g. in the EU, the USA, Asia, or Africa. We help to prepare and conduct your scientific advice meetings and regulatory submissions.
We set-up, support, and evaluate infrastructure for pharmaceutical development including quality-related topics, e.g. Good Practices and ISO 9001:2008. VPM’s experts assess the performance of your quality system and help you in preparing for audits and inspections. Our certified auditors can also perform Good Practices-Audits at your contractors.
VPM can act as legal sponsor (acc. to §4 (24) AMG and ICH-GCP/clinical trials directives 2001/20/EC and 2005/28/EC) for the conduct of clinical trials.