Carlos Pérez, Director General of NYCE spoke with Mexico Health Review on the importance of authorized third parties for Mexico’s pharmaceutical sector.
Q: What aggregated value does NYCE offer that gives it a competitive advantage?
A: Third party organizations create standards for the industry. NYCE has an 18-year-old quality system that relies on the constant improvement of our activities. In our healthcare division, we have three elements to achieve this. First, our management system must control and define metrics to improve our efficiency. Second, we have an internal program called Unifying Hands and Efforts through which collaborators suggest initiatives. Our third element is the satisfaction surveys we send to our clients, where we measure market perception and receive feedback. These three improvement tools have helped us achieve an average of 97 percent customer satisfaction.
All 330 of our staff members have been trained in client service. In fact, we trained COFEPRIS staff on the same subject because it is one of our strengths. Our last COFEPRIS audit was excellent, which motivated us to participate in the National Quality Price. Those are elements that give us a competitive advantage against other companies.
Q: How can you improve processing efficiency for your clients?
A: In January, we launched an online system to assist clients. We have already implemented electronic tools for many of the other industries we work with. In oil and gas, electronics and communications we have a secure online depository to protect information. If an industry accepts our security measures, a confidentiality agreement and responsibility for information management, companies will not have to be present physically for every procedure they need. They will save time and money with us. We are an organism that certifies information security through ISO 2700. We are certifiers of personal data security, giving us another competitive advantage.
Q: What type of healthcare companies are you focused on certifying?
A: When we first started our activities in healthcare, we noticed a large need for medical devices. We focused on that but then we realized that the existing number of authorized third parties fully covered the devices sector, while medicines were ignored. In 2015, we did not reach our pharma goals. Therefore, in 2016 we changed our strategy and focused on medicine rather than medical devices. It was a challenging decision because drugs require much more responsibility and capacity than the other business line. We are working with Pfizer and more organizations are considering our services, mainly because we provide additional benefits. This has given us the opportunity to register several specialized operating cells during 2016.
Q: What does NYCE need from COFEPRIS to improve its operations?
A: The creation of the authorized third party system was a great decision. The government’s acceptance that its internal structure could not deal with the volume of demand was a good move. We have 22 years of experience as a standardization organism, 21 as certification institution and 20 as a verification unit. However, we recognize some third parties are facing operational constraints. The new NOM- 057 regulates the pharmaceutical industry but authorized third parties are not allowed to provide certificates under this standard. NYCE is allowed to verify food content labels for the alimentary industry but is not authorized to verify nutritional information, despite the fact that we operate in the health industry. If we want integral solutions for the market, we should be able to offer both services.
Q: What are NYCE’s plans for the near future?
A: We want to grow our market access by regionalizing our services. We can help organizations export their products to other countries of the Pacific Alliance. Hypothetically speaking, if COFEPRIS closes an agreement with the regulatory authorities of the Pacific Alliance countries, authorized third parties would be able to provide services to the whole region. It is an idea that may help many players in the system.
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