How do you approach managing legal aspects during periods of instability or crises, and how does your legal strategy align with the broader business strategy to ensure the organisation’s resilience?  

I would address this topic by highlighting key steps through the example of one of our most significant projects implemented last year.  

Risk management and proactive approach is key: risk management and a proactive approach are crucial. In our quarterly legal report, we detected an increase in product quality issues, which posed a significant risk to the company. This report, drafted by the legal department, highlighted the most recurrent issues affecting the business, allowing us to act swiftly.  

Engaging with stakeholders for strong sponsorship and support: as the legal function, we immediately reported our findings to the shareholders, directors and auditors to shares objectives and main goals. Transparent communication was key to maintaining their trust and confidence in the legal function getting a strong empowerment in taking the lead and outlining the main corrective actions.  

Communication and internal alignment to encourage employees to embrace the change: effective communication and internal alignment are vital. We cascaded the information to align the management team and all relevant employees with the plan’s benefits and objectives. Clear, simplified, and timely communication was crucial to raising awareness and encouraging employees to embrace the change, keeping morale and personal engagement high.  

Immediate response and execution to achieve results: we quickly assessed the situation to understand the plan’s scope and impact. We revised all procedures concerning quality controls and product releases, as well as the tasks and responsibilities of the team, to identify weaknesses. Procedures, roles, and responsibilities were strengthened to address the most recurrent issues. We established a dedicated crisis response team, comprising members from legal, operations, quality, and regulatory. Workshops on new procedures were organised, and a testing period was set to collect feedback and fine-tune our approach, ensuring all stakeholders were well-prepared and ready to act swiftly.  

Post-Crisis review for key takeaways and continuous learning approach: after six months, we conducted a post-crisis review to evaluate the effectiveness of our response. We continued to monitor the issue through ongoing reporting, keeping the board of directors and key stakeholders informed and updated on achievements.  

By following these steps, we effectively managed the crisis, minimised risks, and strengthened our company’s resilience. This approach and transparent communication also contributed to reinforce the trust and confidence in our legal function, demonstrating our commitment to proactive risk management, stakeholder engagement and continuous improvement. 

What are the main cases or transactions that you have been involved in recently?  

As the group legal function, we assisted and advised the company in the acquisition (May-September 2023) of the whole shares of US Pharma Lab, Inc. a New Jersey based CDMO with a 2022 turnover of more than US$120mn and operations in both the US and China. The company is specialised in the custom development, manufacture and distribution of innovative nutraceutical products including probiotics, vitamins, minerals, supplements, and premium dietary ingredients manufacturing nutraceuticals. It’s been a rather complex operation that required the coordination of several consultants, form tax to legal, as well as the reshaping of the legal governance of the whole group and the integration process of main policies (post-acquisition) which we, as the legal function, entirely managed internally until January 2024. This strategic operation marked the evolution of Biofarma Group into the first global CDMO solely focused on nutraceuticals with a production footprint in the United States, Europe (Italy and France) and China. 

How have you integrated technology into your legal processes, and what impact has this had on efficiency and compliance?  

We integrated AI into our legal workflow and are experiencing a profound impact across multiple aspects. By taking a cautious approach and implementing robust policies, a safe approach toward privacy and data disclosure and scalable solutions, we ensured continuous improvement and fine-tuning over time. Overall, AI tools have dramatically accelerated our processes, ensuring uniformity in document review and contract management across all cases, supporting us in dealing with complex deeds, leading to significant savings in time and resources and allowing us to allocate our efforts more effectively. 

What role does the legal department play in promoting and ensuring corporate social responsibility in your organisation?  

In this area the legal department of Biofarma plays a crucial role. We release several policies that align with corporate and social responsibility goals, including harmonised human right and ethical labour practices. Through our quarterly reporting activities, we identify legal risks associated with ESG and CSR issues, such as regulatory non-compliance or reputational risks, providing summary of takeaways and proposals for our shareholders. The legal function continuously monitors the effectiveness of our codes of conduct, whistleblower policies and improve guidelines for ethical decision-making. The legal department has been embedded in the committee entrusted to support the improvement of ESG/CSR practices, collecting and processing feedback and claims addressed internally.