Delivering Safety Through and for Trustworthy Players
Quality is the cornerstone, deeply ingrained in our values. Through regular audits by and of our business partners, we maintain a circle of trust, all underpinned by our comprehensive certifications.
Since its establishment in 2008, arex PHARMA has evolved into a leading entity in the pharmaceutical wholesale sector, committed to exceeding customer expectations with a diverse portfolio of products and a dedication to excellence. Leveraging advanced digital technologies, we've enhanced our operations and maintained a competitive edge in the dynamic pharmaceutical wholesale industry, underpinned by a strong foundation of quality management, including adherence to international standards and a Quality by Design approach.
Our success is built on robust, carefully nurtured local partnerships, enabling us to thrive on mutual trust and shared growth, further supported by our active participation in national as well as European industry associations. Recognized for our reliability and adaptability through constant auditing and certifications, our commitment to quality assurance and ethical standards sets us apart. arex PHARMA stands as a trusted partner in the pharmaceutical wholesale market, driving innovation and excellence in every aspect of our business.
arex PHARMA is committed to excellence in quality management, integrating principles like Kaizen and CAPA into our continuous improvement ethos, ensuring adherence to international guidelines such as GDP 2013/C 343/01 and DIN EN ISO 9001. Our Quality by Design (QbD) approach embeds quality into every stage of our process, aiming for zero defects and prioritizing ethical standards to enhance efficiency and value for our clients.
As members of Affordable Medicines Europe and the Association of European Drug Distributors (AEDL), we advocate for affordable medicines and support the parallel distribution industry to address shortages and ensure product safety. Our operations are certified under rigorous standards like GDP and ISO 9001, with AEO status recognizing our reliability and security in international trade. Through regular audits and compliance with regulatory checks, we maintain a steadfast commitment to quality assurance, driven by a culture that values integrity, accountability, and continuous process enhancement.
arex PHARMA is firmly grounded in a culture of quality that permeates all aspects of our operation. Our methodologies, which incorporate principles like Kaizen and CAPA, are part of our continuous improvement ethos to maintain high standards.
In adherence to the Good Distribution Practice of Medicinal Products for Human Use (GDP 2013/C 343/01) and in compliance with DIN EN ISO 9001, our quality management practices are thorough and consistent, supported by international guidelines.
Our Quality Management System includes:
The foundation of arex PHARMA’s supply chain is the procurement of certified products, achieved through direct sourcing from manufacturers or carefully selected wholesalers, all under regular audits to ensure quality and reliability.
Our protocol for handling counterfeit products is clear and systematic: isolation, marking as non-saleable, and reporting to the relevant authorities, reinforcing the security of our distribution network.
arex PHARMA is dedicated to the ongoing development of our team, compliance with regulatory checks, cooperation with industry auditors, and regular self-review to uphold our quality assurance, striving for continual enhancement of our processes.
arex PHARMA integrates Quality by Design (QbD) into its processes, adopting a methodical approach to quality that is informed by a range of disciplines, including the precision of aviation systems. Ethical standards are central to our operations, reflecting our commitment to responsible practices.
QbD is a fundamental part of our strategy, aimed at incorporating quality from the initial stages of product development, rather than relying solely on end-stage inspection. This method ensures that quality is a primary focus throughout the production process.
The goal of achieving zero defects is a continuous effort at arex PHARMA. By dedicating the necessary time and resources early in the process, we aim to mitigate potential issues before they arise, thereby enhancing efficiency and value for both our operations and our clients.
Our organizational values, which include integrity and accountability, inform every aspect of our business. These principles guide our interactions, influence our decision-making, and are integral to the relationships we build with our partners.
In our pursuit of excellence, arex PHARMA is committed to maintaining a culture that prioritizes these core values, ensuring a consistent and dependable approach to quality.
Affordable Medicines Europe
Affordable Medicines Europe is an organization representing the parallel distribution industry in Europe, focusing on making medicines more affordable and adding a supplementary layer of product safety. They advocate for licensed parallel distribution, which helps introduce price competition, particularly for patented medicines, and addresses medicine shortages by distributing them from surplus areas to those in need. With an annual turnover of 5.5 billion Euros, they have a substantial influence on the market, holding over 120 member companies across 23 EU/EEA Member States. Their efforts support European healthcare systems and patients by providing cost-effective pharmaceutical options.
AEDL
The Association of European Drug Distributors (AEDL) was established in the second half of 2012 with the aim to unite and represent the interests of drug distributors. Their primary goals include informing members, partners, and the public about the benefits and risks of parallel drug distribution within the EU's free trade system, proposing and discussing with government bodies to ensure the principles of the EU and free trade rights are upheld, defending the interests of their members and partners, and cooperating with international organizations related to international pharmaceutical trade. They are also involved in establishing or financially participating in companies, foundations, associations, and other legal entities to support these aims.
The GDP (Good Distribution Practice) certification is a quality standard for warehousing and distribution that ensures products are consistently stored, handled, and transported under suitable conditions to preserve their quality and integrity. This is especially critical in industries such as pharmaceuticals, where it is essential that products are transported and handled under controlled conditions to guarantee the safety and efficacy of medicines for consumers.
The ISO 9001 certification is an internationally recognized standard for quality management systems that helps organizations of any size and sector improve their process efficiency, increase customer satisfaction, and comply with legal requirements. It is based on a set of quality management principles, including a strong customer focus, the commitment of top management, the process approach, and continual improvement.
The Authorized Economic Operator (AEO) status is granted to companies that meet extensive requirements related to relevant legislation and compliance with security standards, offering the company benefits and other simplified procedures. The Authorized Economic Operator (AEO) status is a certification awarded by customs authorities that recognizes companies as secure and reliable partners in international trade.
An audit by a certified public accountant is a systematic examination process where a company's financial records and statements are reviewed to ensure they present a true and fair view of the company's financial position. Auditors also evaluate compliance with relevant laws and regulations, as well as the effectiveness of internal control systems, to ensure the integrity and reliability of financial reporting.
Certificates to Download
Access our collection of certificates and audit reports through our Downloads page. Explore the documents that demonstrate our commitment to transparency and compliance.