Pharmaceutical regulatory affairs consulting requires precise technical skills, up-to-date knowledge of AIFA and EMA regulations, and the ability to translate complex requirements into concrete actions. View Science supports pharmaceutical, biotech, and life sciences companies at every stage of the regulatory pathway-from initial strategy through post-authorization maintenance-with an integrated approach that combines scientific rigor and communicative clarity.
The process of obtaining Marketing Authorization (MA) is the heart of pharmaceutical regulatory activity. View Science supports companies in preparing and submitting dossiers in eCTD (electronic Common Technical Document) format, ensuring compliance with ICH standards and the requirements of the relevant agencies-AIFA for the Italian market, EMA for European centralized procedures.
Our support includes:
We work both with Companies facing the authorization pathway for the first time and with structured entities that need operational support on high volumes of files or on highly complex products such as orphan drugs, ATMPs, and biotechnology.
The pharmaceutical regulatory landscape is constantly evolving: new EMA regulations, updates to ICH guidelines, revision of AIFA procedures, and the introduction of European HTA Regulation 2021/2282 are constantly redefining the environment in which Companies operate. View Science offers a Regulatory Intelligence service to monitor relevant regulatory changes and translate them into concrete opportunities or actions for your product portfolio.
Our approach sets View Science apart in the Italian regulatory consulting landscape: we do not just manage document compliance, but integrate regulatory strategy with market access, HTA, and scientific communication activities. This means that every dossier, every variation, and every interaction with authorities is also designed taking into account the market access pathway and the value the product has to communicate to payers, clinicians, and institutions.
We operate with a dedicated team model for each Client, built on the specific skills required by the project. We work in synergy to provide quality service at every stage of the product life cycle.
Planning a new registration, managing an existing portfolio, or need regulatory support on a specific product? Contact us for a cognitive call free of charge – We will assess your needs together and propose a tailored path.
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.
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.
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.
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.
