Key team members:

Tiago Ferreira de Matos, General Counsel and Member of the Global Leadership Team

Andrew J. Allen, Senior Director and Legal Counsel

Rafael Lomenso, Global Legal Director

Rita Souza Gomes, Legal Senior Director

Fernanda Meyer, Principal Legal Counsel

James Healy

Team size: Ten

Jurisdictions your role covers: We cover many jurisdictions, but mostly we deal with the following: Switzerland, Portugal, Ireland, US, People’s Republic of China, Macau, Hong Kong, India and Japan.   

What are the most significant cases or transactions that your legal team has recently been involved in?

As a legal team operating within the pharmaceutical industry, we are bound by strict confidentiality obligations that prevent us from disclosing details of the most significant transactions we were involved in. The nature of our work often involves sensitive intellectual property, strategic partnerships, and regulatory matters that are critical to our clients and partners, and we take our duty to protect that information very seriously. However, we can highlight several publicly disclosed initiatives that reflect the dynamic and innovative environment in which our Legal Team operates. These include: 

1) The establishment of ViSync® Technologies, a joint venture between Hovione and iBET (Instituto de Biologia Experimental e Tecnológica, a private, non-profit research institute dedicated to biotechnology research and development), aimed at developing advanced solutions for cell and gene therapy. This collaboration combines Hovione’s pharmaceutical development and manufacturing expertise with iBET’s cutting-edge biotechnological research. 

2) A major expansion of Hovione’s global spray drying capacity, with significant investments in its facilities in New Jersey (USA) and Cork (Ireland). This strategic move enhances capabilities in particle engineering and supports the growing demand for inhalation and oral drug delivery solutions. 

3) A partnership with Dragonfly Technologies to integrate micellar chemistry into Hovione’s manufacturing processes. This sustainable technology enables chemical transformations in water, reducing reliance on organic solvents and lowering the environmental footprint of pharmaceutical production. 

4) The creation of a joint venture with Zerion Pharma to accelerate the development and commercialisation of the Dispersome® technology platform. This initiative aims to improve the solubility and bioavailability of poorly soluble drugs, addressing a key challenge in drug development. 

These public milestones illustrate the breadth of legal and strategic work we support – from complex joint ventures and licensing agreements to sustainability-driven innovation and global expansion projects. 

What factors influence your team’s decision to use external legal services versus handling matters in-house, and what criteria are used to evaluate their performance? 

Our decision to engage external legal counsel is made by the legal team on a case-by-case basis, guided by a combination of strategic, operational, and resource-related factors. There are several factors influencing the use of external counsel: the internal workload (when internal capacity is stretched, we may delegate certain matters to external firms to ensure timely and high-quality support, the complexity of the matter (highly specialised or novel legal issues – such as cross-border litigation, regulatory investigations, or niche IP matters – often require external expertise), subject matter expertise (we engage external counsel when the matter falls outside the core competencies of our in-house team) and resource allocation (strategic use of external firms allows us to optimise internal resources and focus on high-impact or business-critical initiatives). For that purpose, we have established a legal network of preferred law firms, which includes global full-service firms for multi-jurisdictional matters and large-scale transactions and boutique firms with deep expertise in areas such as intellectual property, regulatory compliance, and complex litigation.

This hybrid model ensures both breadth and depth of legal support. As for the performance evaluation criteria, we assess external legal partners based on technical expertise and accuracy, responsiveness and communication, strategic insight and proactivity, cost efficiency and budget adherence, alignment with our business values and risk appetite and post-engagement feedback from internal stakeholders. We also conduct regular reviews to ensure our external partners continue to meet our evolving needs and standards. 

How does your team contribute to the overall business strategy of the company? Can you share an example of a recent legal-led initiative that had a significant impact? 

The nature of our business as a Contract Development and Manufacturing Organization (CDMO) places contracts at the very heart of our operations, making the legal function essential to the execution and success of our corporate strategy. Our team plays a pivotal role in enabling innovation, managing risk, and supporting high-impact initiatives that drive the company forward.

We are fully integrated into cross-functional decision-making, providing proactive legal guidance, safeguarding intellectual property, and structuring complex transactions that align with long-term business goals. For example, we often perform Freedom-to-Operate (FTO) assessments for relevant technologies, which involve a comprehensive global patent landscape analysis and close collaboration with R&D to identify and mitigate IP risks. Other significant examples are related to the legal structuring of joint ventures focused on the co-development of novel platforms. This included negotiating IP licensing-in and licensing-out terms, defining commercialisation rights, and aligning governance structures to support strategic objectives. These examples illustrate how Legal is not just a support function, but a key enabler of innovation, growth, and competitive advantage. 

What are some of the biggest legal or regulatory challenges currently facing your industry, and how is your team preparing to address them? 

One of the most significant legal and regulatory challenges currently facing the global industry (and the pharmaceutical industry in particular) is the growing complexity of geopolitical risk, particularly in relation to international trade and evolving sanctions regimes. In response, our legal team has taken proactive steps to strengthen our Trade Compliance program, ensuring that we consistently operate in full alignment with global trade laws. This includes enhancing internal controls, implementing screening tools to monitor transactions and counterparties, and conducting regular training. These efforts not only help us navigate an increasingly fragmented regulatory landscape but also reinforce our commitment to ethical business practices and the resilience of our global operations.