Guidance to Navigate Evolving Health Standards

 Q: How does VALID distinguish itself when offering its validation services?
A: VALID is focused on becoming the ideal adviser to those clients that want to strengthen their regulatory compliance in the health industry. Health standards in Mexico are constantly evolving and companies in the sector often require advice to stay up to date.
For example, when the Ministry of Health published NOM-059, it did so to introduce better international practices in the production of drugs under the Pharmaceutical Inspection Cooperation Scheme (PICS). Companies need to know and understand this NOM. VALID is fully up-to-speed on this and other regulatory changes and can provide support to national and international companies, facilitate their access to the market, comply with regulations and provide them with greater commercial value for their products and services.
Q: Considering the growth of the medical devices sector in Mexico, are there any plans to expand your services to this niche?
A: For a long time, most of our main clients were national and international pharmaceutical companies but this has changed in recent years and two segments in particular have been growing in Mexico: medical devices and third-party logistics (3PL). Mexico is the largest provider of medical devices in Latin America and there has been an increase in the number of companies that require our services in this area. 3PL companies require more support related to quality systems, cold chain validation and personnel qualification.
Q: Which of VALID's services for the pharmaceutical and medical devices sectors are in greatest demand and what added value do these solutions provide?
A: The main obstacle facing the health industry is finding employees who are trained in all matters related to regulation, especially for cold chain logistics. If the logistics provider, including the driver, is not fully trained on the cold chain, there is a risk that some products will be damaged. The lack of training also impacts the final consumer.
For example, if the logistics operator in charge of delivering medicine to a hospital does not know about cold chain logistics, it can put the hospital at risk and affect the health of patients. The lack of training could be catastrophic for all people involved. VALID specializes in training health professionals on regulatory issues such as ISO, international GAMPs, ICH and PICS guidelines.
Q: What success stories has VALID had thanks to these initiatives?
A: Gerresheimer, a primary packing glass company based in Queretaro; the pharmaceutical company Synthon, in Guadalajara; and Power Ice, a cold chain materials supplier, are among the successful cases of companies that thanks to our consulting services are seeing a change in their performance. Overall, there have been many successes related to VALID’s collaborations with both national and international clients.
Q: With which regulatory entities is VALID connected and what actions do you take to strengthen your relationship with them?
A: We are connected with COFEPRIS but we also regularly attend forums presented by CANIFARMA, Mexico's National College of Pharmaceutical Chemists Biologists (CNQFBs) and the Mexican Association of Professionals in Sanitary Regulation of the Industry of Medical Supplies for Health (AMEPRES).
At these forums, we receive feedback from the regulatory authorities to understand how regulations are trending in Mexico. It is also a way to keep in touch with other companies, associations and entities that are relevant to the industry.