Science in
ACTION
We support companies in managing regulatory strategies throughout the product lifecycle.
We ensure regulatory compliance and effective interaction with relevant authorities.
We reduce time and risk in authorization processes.
We design robust clinical protocols consistent with scientific and regulatory objectives.
We support the definition of endpoints, study design, and methodology.
We set up studies to ensure quality and robustness of data for registration purposes.
We prepare and review dossiers for submission to relevant authorities.
We integrate scientific, clinical and regulatory content maximizing the likelihood of approval by reducing potential criticality.
We support value-based pricing and market access strategies. We prepare documentation for negotiations with regulators and payers.
We optimize product economic positioning.
We evaluate and enhance the degree of therapeutic innovation of products in accordance with the requirements of Regulatory Authorities with the preparation of dossiers for innovativeness requests.
We strengthen competitive and regulatory positioning.
Support and development for applications under Law 648/96, 5% Fund, Compassionate Use, Law 94/98
We simulate negotiations with regulatory authorities and payers.
We prepare the business team to handle objections and critical issues.
We improve performance and outcomes of real negotiations.
We perform advanced statistical analysis on clinical and real-world data. We support interpretation and exploitation of results. We guarantee methodological soundness and scientific rigor.
We prepare comprehensive Clinical Study Reports in accordance with guidelines.
We integrate clinical data, analysis, and interpretations in a clear manner.
We design and manage advisory boards with high-profile experts.
We facilitate strategic discussions between the company and stakeholders.
We generate insights useful for clinical and strategic decisions.
We assess the robustness of regulatory and access strategies.
We simulate critical scenarios and possible objections from authorities.
We strengthen business preparedness in complex contexts.
We offer customized training programs on regulatory and scientific topics designed to support annual mandatory training.
We update operations teams on current regulations, best practices, and industry developments.
We create 3D animations to explain mechanisms of action of drugs and medical devices.
We transform scientific content into intuitive visual experiences: ideal for education, marketing and medical-scientific communication.
We create explanatory videos for clinical protocols and procedures.
We facilitate understanding for health care providers and patients.
We reduce operational errors and improve study adherence.
We develop videos to support the process of understanding informed consent.
We make content clear, accessible, and understandable.
We increase patient engagement and awareness.
We produce high-impact visual materials for scientific content.
We translate complex data into clear and effective infographics.
We support publications, conferences, and corporate communications.
We build distinctive visual identities for products.
We create branding and strategic positioning.
We reinforce recognizability and perceived value.
We adapt global materials to the Italian regulatory environment.
We ensure consistency with national guidelines and requirements.
We optimize the effectiveness of communication on the ground.
We plan and implement content dissemination strategies.
We maximize visibility on scientific and digital channels.
We increase the impact of results and communication.
SENIOR CONSULTANT - ADVANCED THERAPY
SENIOR ADVISOR - VALUE & ACCESS STRATEGY
SENIOR CONSULTANT - ADVANCED THERAPY
SENIOR ADVISOR - VALUE & ACCESS STRATEGY
Fabrizio is a professional with scientific background, Founder and currently CEO of ViewScience. His education is developed in the field of biotechnology, with a bachelor’s and a master’s degree in Medical Biotechnology at the University of Rome “Tor Vergata,” followed by a Master’s degree in clinical and preclinical drug development at the Catholic University of the Sacred Heart, with focus on technical-scientific, regulatory and ethical aspects. During his career, he has gained expertise in regulatory affairs and pharmaceutical consulting, working alongside companies in product enhancement from a strategic point of view and in scientific communication.
Ludovica is a Senior Leader with more than 30 years of experience in the life sciences sector, with a strong results orientation and an established ability to translate scientific research into accessible therapeutic solutions. He has gained significant experience in the area of market access, successfully contributing to processes of drug enhancement and availability for patients. Throughout his career he has built a wide institutional network, actively collaborating with public stakeholders and policy makers. He also has strong expertise in Price and Reimbursement negotiations with Italian regulatory authorities, working in multiple therapeutic areas including chronic non-communicable diseases, oncology, hematology, virology and rare diseases. In parallel, she is active as a business angel in the evaluation and support of innovative startups.
Giovanni is a leading international expert in the field of advanced therapies, with consolidated experience in regulatory aspects related to the use of cultured cells for clinical applications and in cell and gene therapies. He works as an expert for the Italian Government and the European Medicines Agency (EMA) and was Chair of the CTP group at the European Directorate for the Quality of Medicines (EDQM) from 2010 to 2018. He currently serves as Scientific Director of the TEDDY network (Bari 2026), Regulatory Advisor for the Center for Biological and Pharmacological Evaluations (CVBF, Pavia), and Senior Advisor for the European EATRIS infrastructure. He holds a PhD in Biological Sciences from the University of Naples and has developed his scientific career in the study of mechanisms of stem cell proliferation and differentiation, with research experience in the United States and at the Istituto Superiore di Sanità, contributing more than 200 scientific publications.
Alessandro is a professional with over 35 years of experience in the pharmaceutical and biotech industry, gained through roles of increasing responsibility in areas such as marketing, medical affairs, outcomes research, health economics, value access, and HTA. He has worked with major international companies including Merck Sharp & Dohme, Sanofi-Pasteur, Baxter, Baxalta-Shire and Organon. He has strong expertise in pricing and reimbursement processes, with 28 successfully completed procedures in several European countries (UK, Italy, France and Spain). Throughout his career, he has designed and implemented high-impact programs to demonstrate the clinical and economic value, sustainability, and effectiveness of new healthcare solutions. He combines his professional activities with international academic collaboration, particularly with UK university centers, and is currently an external member of the Statistics for Health Economic Evaluation Group at University College London. He also has a wide network of professional contacts that includes key European public decision makers and has contributed numerous publications in scientific and health economics journals.
Fabrizio is a professional with scientific background, Founder and currently CEO of ViewScience. His education is developed in the field of biotechnology, with a bachelor’s and a master’s degree in Medical Biotechnology at the University of Rome “Tor Vergata,” followed by a Master’s degree in clinical and preclinical drug development at the Catholic University of the Sacred Heart, with focus on technical-scientific, regulatory and ethical aspects. During his career, he has gained expertise in regulatory affairs and pharmaceutical consulting, working alongside companies in product enhancement from a strategic point of view and in scientific communication.
Ludovica is a Senior Leader with more than 30 years of experience in the life sciences sector, with a strong results orientation and an established ability to translate scientific research into accessible therapeutic solutions. He has gained significant experience in the area of market access, successfully contributing to processes of drug enhancement and availability for patients. Throughout his career he has built a wide institutional network, actively collaborating with public stakeholders and policy makers. He also has strong expertise in Price and Reimbursement negotiations with Italian regulatory authorities, working in multiple therapeutic areas including chronic non-communicable diseases, oncology, hematology, virology and rare diseases. In parallel, she is active as a business angel in the evaluation and support of innovative startups.
Giovanni is a leading international expert in the field of advanced therapies, with consolidated experience in regulatory aspects related to the use of cultured cells for clinical applications and in cell and gene therapies. He works as an expert for the Italian Government and the European Medicines Agency (EMA) and was Chair of the CTP group at the European Directorate for the Quality of Medicines (EDQM) from 2010 to 2018. He currently serves as Scientific Director of the TEDDY network (Bari 2026), Regulatory Advisor for the Center for Biological and Pharmacological Evaluations (CVBF, Pavia), and Senior Advisor for the European EATRIS infrastructure. He holds a PhD in Biological Sciences from the University of Naples and has developed his scientific career in the study of mechanisms of stem cell proliferation and differentiation, with research experience in the United States and at the Istituto Superiore di Sanità, contributing more than 200 scientific publications.
Alessandro is a professional with over 35 years of experience in the pharmaceutical and biotech industry, gained through roles of increasing responsibility in areas such as marketing, medical affairs, outcomes research, health economics, value access, and HTA. He has worked with major international companies including Merck Sharp & Dohme, Sanofi-Pasteur, Baxter, Baxalta-Shire and Organon. He has strong expertise in pricing and reimbursement processes, with 28 successfully completed procedures in several European countries (UK, Italy, France and Spain). Throughout his career, he has designed and implemented high-impact programs to demonstrate the clinical and economic value, sustainability, and effectiveness of new healthcare solutions. He combines his professional activities with international academic collaboration, particularly with UK university centers, and is currently an external member of the Statistics for Health Economic Evaluation Group at University College London. He also has a wide network of professional contacts that includes key European public decision makers and has contributed numerous publications in scientific and health economics journals.