Quality Is an Investment in Healthcare, Society

Q: What makes PQE Group stand out in the market?

A: PQE Group stands out thanks to its unique value proposition. Unlike many competitors, PQE Group does not solely prioritize technology solutions; it offers impartial advice and maintains a holistic view of its clients' requirements. Moreover, the group has a profound grasp of both technology and life sciences, enabling it to excel in serving clients in these sectors. The Group also has a widespread global footprint, encompassing 23 subsidiary locations.

Q: What additional value-added services does the company offer to its clients?

A: PQE Group’s services go beyond addressing regulatory complexities, contributing to the long-term success of clients. The group has established long-standing relationships with many major clients throughout its 25-year history, demonstrating its proven ability to support client achievements. Through extensive collaboration with regulators in the EU, the US and other countries, PQE Group offers clients a comprehensive understanding of regulatory landscapes and emerging trends. The group's expertise extends beyond regulatory compliance, encompassing various areas, such as technology, machinery, equipment, engineering and now the medical field.

Q: What was the impact from the company’s adjustment of work organization during the pandemic?

A: The company's adjustments during the pandemic bolstered its resilience and adaptability. By diversifying quality aspects and expanding into multiple countries, PQE Group and its clients have gained the indirect advantage of being able to navigate through rapidly changing situations. If a disruption occurs in one country, PQE Group can assist its clients in transitioning to another location. For example, when the pandemic highlighted supply chains problems, some clients found the US market to be more appealing. PQE Group supported them in developing the necessary competencies and regulatory models for success. This adaptable approach and readiness for change have become essential for companies worldwide. Instead of trying to predict specific outcomes, being prepared for any changes that may arise has proven to be the best strategy.

Q: How does your company tailor its solutions to meet the specific requirements and regulations in Mexico?

A: To meet Mexico’s requirements and regulations, our company has actively participated in several initiatives, including some concerning pharmacies and IT. We maintain a close relationship with regulatory bodies and are involved in the creation of new regulations, ensuring that our knowledge is up to date. Given Mexico's close ties with the US Food and Drug Administration (FDA), our relationship with this agency is also valuable to our clients.

We recognize the diverse landscape of companies in Mexico and customize our validation efforts based on each company's unique circumstances and risk analysis. By considering factors like critical processes and computerized system validation (CSA), we provide a sustainable model that caters to individual company needs, as there is no one-size-fits-all solution for validation and complexity.

Q: What obstacles hinder the pharmaceutical sector in Mexico from fully capitalizing on nearshoring and API advancements?

A: Despite having potential and favorable labor costs, the Mexican industry lacks the proactive approach needed to seize this opportunity. The challenges go beyond financial support; they involve effective marketing and branding to highlight the quality of Mexico's pharmaceutical industry. The sector must overcome these obstacles to position itself as the preferred destination for API production. By leveraging its proximity to the US and utilizing the expertise of industry professionals, Mexico has the potential to become a competitive alternative to countries like India or China. The Mexican industry often adopts a conservative and timid approach, unlike the more aggressive and capital-driven approach observed in Asia.

Q: How does PQE Group collaborate with Mexican regulatory authorities and industry stakeholders?

A: PQE Group actively engages with prominent organizations, regulatory authorities and industry stakeholders to promote best practices and advance biotechnological products. We recognize the value of research expertise that can be obtained from neighboring countries. PQE Group adheres to the rules observed in the US when operating in Mexico.

Mexico offers cost-effective labor and the ability to transport products swiftly by land to the US. Mexico also has strong technological capabilities and expertise. By establishing trust and demonstrating potential opportunities in Mexico, PQE Group aims to provide secure and effective marketing solutions for US companies. Ultimately, the key lies in the private sector's belief in its capabilities to compete with its Asian counterparts.

Q: How does PQE Group help customers in Mexico address malware and software infection challenges?

A: PQE Group has made significant investments in digitalization and cybersecurity over the years. It has a dedicated team capable of managing the entire life cycle of cybersecurity, including network design, security provisions and security assessments. It also provides training and support to companies in designing effective cybersecurity approaches. PQE Group has significant expertise in both medical devices and cybersecurity, allowing it to offer comprehensive solutions. The company understands the unique regulations governing medical device software and can provide a complete package tailored to the needs of companies operating in the Mexican market. PQE Group emphasizes the importance of careful validation of architectural solutions to ensure data security, especially considering the rising popularity of medical device software in healthcare.

Q: How does PQE Group evaluate and assist in Mexican companies' compliance with the updated requirements of NOM-241-SSA1-2021?

A: PQE Group has a dedicated team that helps Mexican companies efficiently comply with NOM-241-SSA1-2021, the new medical device regulation. We have a checklist tailored to this regulation. During the assessment process, we advise clients to not only evaluate compliance but also consider international regulations. This comprehensive approach ensures a holistic understanding of the company's compliance status. By prioritizing the gap assessment, PQE Group aims to minimize the time spent on auditing and maximize the focus on remediation, if necessary.

Q: What are the anticipated challenges that PQE Group foresees in the life science industry?

A: The life science industry runs the risk of becoming compliant after the pandemic. It is crucial to prioritize the stability of the supply chain, as any disruptions in sourcing materials for medical devices or pharmaceuticals can lead to significant issues. Therefore, the industry must shift its focus from solely seeking lower prices to ensuring a secure and reliable supply chain. This necessitates a comprehensive re-evaluation that places a strong emphasis on safety.

Q: What are your goals and objectives for 2023 and the beginning of 2024?

A: In the near term, our primary objective is to focus on the clinical and medical fields. The long-term goal is to foster collaboration among individuals from diverse countries, leveraging their unique cultural backgrounds and competencies to create a harmonious and sustainable work environment. An approach that emphasizes diversity contributes to the promotion of unity.

PQE Group is a women-owned Contract Quality Organization and Complete Quality Solution provider for GCP, GLP, GMP, GVP & GDP areas in the Life Science Industry