Drug Development and Regulation (DDR) is an independent European consultancy company, located in Barcelona, Amsterdam and London, focused on providing appropriate scientific and regulatory expertise for the global development and registration of Drugs and Medical Devices.
DDR and its Network of Experts provide strategic and operational services for the development of new Drugs and Health Technologies. Its services are most suited to pharma and biotech companies, governmental projects on drug regulation, research and innovation, and academic initiatives on education and training.
Our team consists of experienced specialists with scientific and multi-disciplinary backgrounds, who have a track record of successful developments in Europe and in other regions.
The team has in-depth knowledge of Drugs, Medical Devices and Combination Products development and regulation in Europe and worldwide. This enables us to understand and meet your company needs and provide customized advice.
Xavier Luria, MD
CEO / Founder
Beate R.Schmidt, MSc
Senior Scientific Regulatory Manager
Diane Cowie, BSc
Cristina Gil, PhD
Daniel García, MsPharm
Senior Regulatory Manager
Ainoa Forteza, MSc
Senior Regulatory Manager
Ingrid Vilimelis, MsPharm
Pep Xixons, MsPharm
Eric Armenteros, MSc
Mercè Guerra, MSc
Paula Meler, MSc
Tabatha Bourgois, MScEng
Business Development Manager
International Network of Experts
The Network consists of highly qualified and experienced specialists from regulatory bodies, academia, the industry and other well recognized consulting companies. It provides appropriate expertise, knowledge and capabilities for a global approach and operational support.
Identifying which expert can best address a specific problem is crucial for resolving the issue in a fast and optimal manner. DDR will help you choose the best expert by correctly defining the issue to be solved.
The most appropriate experts are assigned to each project according to the objectives and in agreement with the Sponsor.
Collaboration (EMA Solutions)
EMA Solutions, a partnership between DDR and Kinesys Consulting, provides extensive, in-depth added value to the management of Oral Explanations (OEs) and other critical assessments, which represent challenging aspects of regulatory applications.
EMA Solutions provides an impressive network of experts, mainly composed of former regulators and senior-level industry executives, who together provide a unique insight into the European Medicines Agency (EMA), the Committee on Human Medicinal Products (CHMP) and other EMA Committee expectations.
Our combined experience of working on “both sides” of Marketing Authorization Applications – in Industry, as well as with Academia and Regulatory bodies – allows us to help clients tailor their written and oral communication with EMA in an optimum fashion in order to reduce risk and ensure the greatest chance of success.
EMA Solutions guarantees the greatest level of professionalism, together with the highest scientific and regulatory standards. These two aspects are recognized as key factors in successfully navigating OEs and critical assessments at the EMA.