Services and Training

Bio/pharmaceutical companies

DDR offers expertise in Drug Development processes and in Drug Regulation. In particular, our consulting services are oriented to positively contribute to the success rate of drug development programs, avoiding common pitfalls from the pre-clinical, clinical and regulatory point of view and identifying fast and cost-efficient ways to get products successfully authorized and marketed.

  • Strategic approach to R&D program design and definition of regulatory strategies at corporate level and for concrete drug development programs
  • Contribute to small and medium-sized research-oriented companies to move their business forward into an efficient drug development program
  • Identifying and designing key studies required for an efficient clinical development program and in particular a fast way to Proof-of-Concept considering scientific and regulatory requirements
  • Strategic and operational development of regulatory issues before and after authorization and marketing
  • Help companies on identifying and designing post-authorization product development
  • Assessment of development and market opportunities for drugs that have failed during their initial development program
  • Contribution to cost-effective set up or reengineering of clinical development structure including flexible outsourcing strategy
  • Assessing opportunities for drugs under research or development phases to become attractive for venture capital companies
  • Clinical and Regulatory operational support during all drug development phases
  • Customized projects reviewing organizational structures and functionalities of biopharma companies and service providers

Three additional services covering all product life cycle stages are provided:

  • Relevant expertise in building methodologies and assessment processes on Benefit/Risk Evaluation (N. Zafiropoulos, L. Phillips, F. Pignatti, X. Luria; Regulatory Rapporteur - Vol 9, No 6, June 2012)
  • Preparation for interactions with Regulatory Agencies
  • Assist investors in evaluating opportunities in Life Science companies

Governmental projects on Drug Regulation and Research and Innovation Initiatives

DDR has acquired expertise in the Drug Regulation area, which allows DDR to support Governmental organizations in

  • Strategic support on Drug Regulation
  • Strategic support on governmental initiatives supporting Research and Innovation
  • Designing development of strategies
  • Hands-on support to develop and implement new and updated regulations
  • Training of staff on regulatory standards and regular up-to-date programs
  • Support projects on promoting Research and Innovation
  • Contribute to communication with stakeholders

Academic: Educational and Training

DDR has long-standing experience in Education & Training activities. Dr. Xavier Luria is normally lecturing at various Universities and Business Schools in Europe, USA, Asia and Latin America and he is Professor of Life Science Regulation at the IE Business School (http://www.ie.edu/business-school/). Additionally, he provides education and training services to many other courses and conferences and customized in-house training on Benefit Risk Evaluation.