Consulting and Services

From Bench to Product – We know how to facilitate development for medical progress

Are you responsible for a high-quality biotech product pipeline? On a daily basis you have to make high-stake decisions regarding your product development plan?

We know how to navigate in this uncertain and complex environment.

Within the last decade, VPM has successfully managed the development of promising biopharmaceutical candidates, ranging from small molecules, recombinant proteins up to gene-modified live vaccines and ATMPs, and brought them from academic research into clinical phase I and II trials. VPM achieved business proof of concept by successfully out-licensing three candidates out of five.

With the out-licensing of our products we shifted our business focus on consulting and services adding value to client projects based on our in-depth experience. For us, effective project management and sound product development plans are key for success. Our clients are small, medium and large biopharmaceutical enterprises, as well as private funding organizations, and research groups. Our consulting and service offers refer to the entire product development value chain as VPM has experienced and successfully mastered each of these value points for itself.

We understand how complex product development is, because we did it ourselves. Let us be a competent partner at your side for a secure route to a successful product

Services:

Regulatory Interactions

Regulatory consultancy

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.

Development Pharmaceuticals

Translational Project Management

VPM offers services in the areas of development planning and project 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 centers, we identify and manage the optimal development path for your product.

Valuation and Evaluation

Valuation & Due Diligence

VPM carries out conclusive valuations and supports due diligence processes from buyer and seller perspective considering science, technology and development potential as well as financial and marketing aspects, e.g. market analyses and rNPV calculations.

Organisational and Quality Management

Organizational & Quality Management

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.

Designated Sponsor

Designated Sponsor

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.