About Us

The Company

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.

Team

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

Xavier Luria, MD

CEO / Founder

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Beate R.Schmidt, MSc

Senior Scientific Regulatory Manager
Collaboration

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Diane Cowie, BSc

Diane Cowie, BSc

CMC Expert
Collaboration

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Cristina Gil, PhD

Cristina Gil, PhD

Medical Writter
Collaboration

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Daniel García, MsPharm

Daniel García, MsPharm

Senior Regulatory Manager

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Ainoa Forteza, MSc

Ainoa Forteza, MSc

Senior Regulatory Manager

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Ingrid Vilimelis, MsPharm

Ingrid Vilimelis, MsPharm

Regulatory Manager

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Pep Xixons, MsPharm

Pep Xixons, MsPharm

Regulatory Manager

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Eric Armenteros, MSc

Eric Armenteros, MSc

Regulatory Officer

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Mercè Guerra, MSc

Mercè Guerra, MSc

Regulatory Officer

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Paula Meler, MSc

Paula Meler, MSc

Regulatory Officer

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Tabatha Burgois, MScEng

Tabatha Bourgois, MScEng

Business Development Manager

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Alba Rando

Alba Rando

Assistant Manager

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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.

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