Long-Term Strategy Needed In Regulatory Affairs

Q: How does Sioltalife help the pharmaceutical businesses it works with?

A: In the pharmaceutical industry, our goal is to be a strategic partner helping in the technical feed for strategic projects as well as indirect suppliers to establish their business, whether you are a Mexican client or a client from abroad. The sector is open to working with us because we offer professional expertise based on years of experience. When we develop business operations, we work with our clients to define their objectives and priorities, and plan all the steps that need to be taken. This is accompanied by a timeline that sets out deadlines and specific goals. Our coaching and training services allow our clients to gain the necessary know-how. The pharmaceutical industry faces a many challenges, such as regulatory pressures. We work together to reach the best possible outcome.

Q: How is pharmaceutical regulation changing?

A: Regulation has become more detailed and is being enforced more strictly. Before, you could plan for an inspection, but now you need to be solving and implementing changes immediately. Also, the administration wants to open the market to more foreign medications so the norms have to be updated to fit the new circumstances. Several norms are under review, and a few have been published. With respect to national companies, such as pharmaceutical manufacturers, I believe it is important to have a long-term strategy when it comes to regulatory compliance. Many have a system in place, but it is focused on the national market. When the opportunity comes to export, they suddenly do not meet the requirements. Regulation is a complex topic as the industry continues to evolve.

The level of uncertainty among companies regarding new regulations certainly helps us. We can help define the right strategies for companies to tackle this new environment. Many foreign companies, for example, are reluctant to invest in Mexico, but this can also be the moment to capitalize on opportunities. With the enforcement of USMCA, you will see a major upturn in the area of manufacturing of medications and medical devices. Medical devices are already a burgeoning sector with a strong cluster in Tijuana and fast growth in Guadalajara. Many foreign businesses are looking to come to Mexico to benefit from these conditions.

Q: What opportunities do you see to help foreign companies within the current climate?

A: The national pharmaceutical industry will have to make strategic decisions having the appropriate talent for its execution and time as a critical factor. Given that the professional profile is focused on the operation and implementation of all regulatory requirements, our proposal is to be part of its multidisciplinary teams, managing and accelerating processes for effective and efficient decision-making, guaranteeing timely execution, linking talent, providing strategic information and continuous training as part of our value proposition.

We are certain that the new normal that is coming with the COVID-19 outbreak will represent change, flexibility, effective use of resources, but above all, a strong multisectoral network with high agility in communication and resource management to accelerate the processes that make up the consolidation of a long-term strategy. Overall, comply with deadlines is our commitment and purpose.

Sioltalife is a Mexican consultancy specialized in business development. It has strong expertise to help foreign companies achieve a soft-landing in Mexico