We provide the strategic direction, local market knowledge, expertise and people needed to obtain successful Regulatory Affairs and Market Access outcomes within international markets.
We provide the strategic direction, local market knowledge, expertise and people needed to obtain successful Regulatory Affairs and Market Access outcomes within international markets.
Our Experience and Expertise
Our coverage of the European market supports Life science companies in developing and implementing Regulatory and Market Access strategies on European and national level as required. Our multi-disciplinary experts will facilitate and guide you through the most appropriate strategy to register your product in Europe. Our grounded expertise in managing European regulatory procedures together with an in-depth knowledge of the local requirements for a better regulatory strategy and understanding of the national cultural nuances is vital to your success.
The benefits of working with Assion
Over many years our founder companies have been committed to working together on multiple Regulatory projects and applying a multi-disciplinary approach with our Market Access teams that incorporates buy in from stakeholders across our client’s organization to achieve successful outcomes. These achievements and the subsequent feedback from our clients have led us to formalize this methodology and create one business, where all resources are dedicated on delivering this integrated approach and improving the outcomes on the projects we provide.
Close proximity to the EMA
The European Medicines Agency (EMA) is the Agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU for products centrally approved.
Our office in Amsterdam is strategically situated minutes away from the EMA offices. This has enabled our team to build an extensive network within the organization. This proximity has assisted Assion in acquiring the necessary expertise and experience that has supported companies to gain approval through the centralized procedure.
Senior Team
The Assion Senior Team has over 50 years shared experience and is supported by an exceptionally strong team with diverse expertise to ensure that every project is delivered to achieve the greatest results. View our Senior Team bios…
Anita Falezza
Anita Falezza Managing Director
Anita Falezza founded Assion in 2020, having previously founded Regulatory Pharma Net s.r.l. in 1999. Anita has held various positions in the pharmaceutical industry since 1989. With 30 years’ experience in the market her activities are focused on the consulting and strategic coordination of Drug Development, Regulatory Affairs and Market Access projects across international markets, providing strategic advice for interacting with international and national regulatory authorities (e.g. EMA, FDA, BfArM, AIFA, etc.), maximising the use of the regulatory mechanisms using an interdisciplinary approach to obtain regulatory and market access goals.
Anita is also directly involved in Scientific Advices, Paediatric Investigation Plans, Orphan Drug Designations, Drug Development Plans, Centralised, Decentralised, and Mutual Recognition Procedures, Price and reimbursement procedures, pre-INDs, INDs, NDAs, BLAs being in continuous contact with the evaluating authorities.
She has remarkable experience in Innovative Products, Anticancer products, Biological and Biotechnological Products, and Advanced Therapies and regulalry participates in due diligence and negotiations for licensing and acquisitions.
Anita is a member of Organisations of Professionals (e.g. DIA, TOPRA) as well as an active member of EUCOPE, and other local industry associations.
Jürgen Reiher
Jürgen Reiher Managing Director
Jürgen leads all our strategic planning and commercial implementation. Prior to joining Assion, throughout his career in pharma and as a consultant, he’s led the development of multiple strategic plans, complex market access dossiers, KOL engagements and management consulting projects.
Alessandro Bider
Alessandro Bider Global Business Development
Alessandro has very specific experience and expertise in the multinational Pharma industry, spanning across sales, marketing and international project management areas. Alessandro is well versed at combining a strategic and holistic approach to proactively address client’s challenges.
Alessandro understands the value of innovation and new ideas to help meet healthcare companies needs and to support the creation of new opportunities, to exceed the objectives laid out in every project.