Salvador Berríos
Director General
Graciela Aguilar
Graciela Aguilar
Technical and Regulatory Director
View from the Top

Regulatory Compliance Is an Advantage

Wed, 09/07/2016 - 10:08

Q: Only 1.2 percent of multinational clinical trials are conducted in Mexico. What strategies has Qually implemented to attract more studies and clients into the country?

GA: Qually signs agreements with third party clinical trial institutions, while the company monitors studies and analyzes samples. We conduct our analysis through state- of-the-art analytical instrumentation. After obtaining comparative results between generics and referenced drugs, Qually conducts statistical analysis based on COFEPRIS norms and regulations, later producing a comprehensive report. The company’s strategy to secure business is directly correlated to its capabilities as an analytical entity. Qually’s certifications and platforms have validated its mechanisms giving us an edge against our competitors. We make our analytic methodology available to clinical trial sponsors and we get reliable results in a timely manner.

Q: What do you perceive as the biggest challenges the industry is facing?

GA: Even though the Mexican market does not have many third party clinical research entities, competition will continue as Qually’s biggest challenge. When companies like us initially began the demand for our services was booming. Clinical trial studies grew substantially as compliance with the 2005-2010 regulations overloaded the industry.

Most analytical methods were provided by Qually sticking to its trademark responsiveness and timeliness. We are usually given four weeks to conduct analytical studies howeverourexcellentequipmenttakesaslittleasoneweek to produce reliable reports. As such, we retrained most of the business servicing a big part of the demand. Not every contract research organization (CRO) is capable of handling such a workload with high-efficiency levels as sensitive equipment and analytical mechanisms like Qually’s require large investments. Although competition became fiercer as the demand grew thinner we have the mechanisms to guarantee prompt health-record-approvals. There is little room for inaccuracies as the financial stakes are enormous.

SB: Maintaining COFEPRIS certification is one of Qually’s main strategic pillars, which calls for ongoing investment every two years. Adapting to new norms requires large expenditure in both financial and human capital. COFEPRIS demands that we adapt to newer and better quality- management systems and although we have complied systemically, doing so is quite problematic. Training our workforce is essential as we must show comprehensive technical competence at all times. Qually is an extension to Mexico’s sanitary authority and although its clients are extremely important, producing comprehensive and accurate reports is even more so.

Q: How is Qually developing new processes, products and services, seeing as only 0.45 percent of Mexico’s GDP is allocated to R&D?

SB: Rather than innovating our services we are adapting our laboratories. In return, we will offer a broader line of services. At a policy level, Qually cannot innovate, because the company must keep in line with the enforced legal framework. By continuously investing in our operations we can better service our clients. Thereafter, internal growth will follow by expanding our technical capabilities. Instead of developing innovation, Qually uses innovation. We must have sufficient purchasing strength to refurbish our facilities.

GA: Innovations are becoming increasingly stagnant worldwide. Between 2015 and 2018 a large number of high cost and high specialization patents will expire. Qually starts its generic bioequivalence studies two years before patent expirations, licensing them with COFEPRIS immediately after. Promptly filing dossiers drops a product’s costs by at least 60 percent.

Q: What are Qually’s ambitions and where will we see the company in 2016?

GA: Qually is looking to expand its operations in Mexico. We will look into different regions as more space is needed. We have reached full capacity in our facility putting a halt on our goal. So far, we have looked at Guadalajara and Toluca.