Altamira Therapeutics Announces Extended ISO 13485 Quality Management System Certification for Bentrio Nasal Spray
Altamira Therapeutics has announced an extended ISO 13485 certification for its quality management system, now including production activities for Bentrio nasal spray. This certification covers the entire process from design and development to production and distribution.
The extended certification is a significant milestone in Altamira's growth strategy for Bentrio, which involves collaboration with a strategic contract manufacturer and an expanding network of international distributors. Thomas Meyer, Chairman and CEO of Altamira Medica, emphasized the importance of this achievement in ensuring Bentrio's compliance with high quality standards and regulatory requirements.
This development supports Altamira's efforts to expand the reach of Bentrio in the market, reinforcing its commitment to quality and regulatory compliance in the medical device industry.
Altamira Therapeutics ha annunciato un'estensione della certificazione ISO 13485 per il suo sistema di gestione della qualità, che ora include anche le attività di produzione per Bentrio spray nasale. Questa certificazione copre l'intero processo, dalla progettazione e sviluppo fino alla produzione e distribuzione.
La certificazione estesa rappresenta una tappa significativa nella strategia di crescita di Altamira per Bentrio, che prevede la collaborazione con un produttore contrattuale strategico e un numero crescente di distributori internazionali. Thomas Meyer, Presidente e CEO di Altamira Medica, ha sottolineato l'importanza di questo traguardo per garantire la conformità di Bentrio con gli elevati standard di qualità e i requisiti normativi.
Questo sviluppo sostiene gli sforzi di Altamira per ampliare la diffusione di Bentrio nel mercato, rafforzando il suo impegno per la qualità e la conformità normativa nell'industria dei dispositivi medici.
Altamira Therapeutics ha anunciado una extensión de la certificación ISO 13485 para su sistema de gestión de calidad, que ahora incluye las actividades de producción para Bentrio spray nasal. Esta certificación abarca todo el proceso, desde el diseño y desarrollo hasta la producción y distribución.
La certificación extendida es un hito significativo en la estrategia de crecimiento de Altamira para Bentrio, que implica la colaboración con un fabricante contratista estratégico y una red en expansión de distribuidores internacionales. Thomas Meyer, Presidente y CEO de Altamira Medica, enfatizó la importancia de este logro para asegurar el cumplimiento de Bentrio con altos estándares de calidad y requisitos regulatorios.
Este desarrollo apoya los esfuerzos de Altamira por expandir el alcance de Bentrio en el mercado, reforzando su compromiso con la calidad y la conformidad regulatoria en la industria de dispositivos médicos.
알타미라 테라퓨틱스(Altamira Therapeutics)는 이제 벤트리오(Bentrio) 비강 스프레이의 생산 활동을 포함하는 품질 관리 시스템에 대한 ISO 13485 인증 연장을 발표했습니다. 이 인증은 설계 및 개발에서 생산 및 유통에 이르는 전체 과정을 포괄합니다.
연장된 인증은 벤트리오의 성장 전략에서 중요한 이정표로, 전략적 계약 제조업체와의 협업 및 국제 유통업체 네트워크 확대를 포함합니다. 알타미라 메디카(Altamira Medica)의 회장 겸 CEO인 토마스 마이어(Thomas Meyer)는 벤트리오가 높은 품질 기준과 규제 요구 사항을 준수하는 것이 이 성취의 중요성을 강조했습니다.
이번 발전은 알타미라가 벤트리오의 시장 접근성을 확장하기 위한 노력을 지원하며, 의료 기기 산업에서 품질 및 규제 준수에 대한 헌신을 강화합니다.
Altamira Therapeutics a annoncé une certification ISO 13485 étendue pour son système de gestion de la qualité, qui inclut désormais les activités de production pour Bentrio spray nasal. Cette certification couvre l'ensemble du processus, de la conception et développement à la production et distribution.
La certification étendue représente une étape significative dans la stratégie de croissance d'Altamira pour Bentrio, qui implique une collaboration avec un fabricant sous contrat stratégique et un réseau en expansion de distributeurs internationaux. Thomas Meyer, Président et CEO d'Altamira Medica, a souligné l'importance de cette réalisation pour garantir la conformité de Bentrio aux normes de qualité élevées et aux exigences réglementaires.
Ce développement soutient les efforts d'Altamira pour étendre la portée de Bentrio sur le marché, renforçant son engagement envers la qualité et la conformité réglementaire dans l'industrie des dispositifs médicaux.
Altamira Therapeutics hat eine erweiterte ISO 13485-Zertifizierung für ihr Qualitätsmanagementsystem bekannt gegeben, die nun auch Produktionsaktivitäten für Bentrio Nasenspray umfasst. Diese Zertifizierung deckt den gesamten Prozess von der Gestaltung und Entwicklung bis hin zur Produktion und Verteilung ab.
Die erweiterte Zertifizierung ist ein bedeutender Meilenstein in Altamiras Wachstumsstrategie für Bentrio, die die Zusammenarbeit mit einem strategischen Auftragshersteller und einem wachsenden Netzwerk internationaler Distributoren umfasst. Thomas Meyer, Vorsitzender und CEO von Altamira Medica, betonte die Bedeutung dieses Erfolgs, um die Einhaltung der hohen Qualitätsstandards und regulatorischen Anforderungen von Bentrio sicherzustellen.
Diese Entwicklung unterstützt Altamiras Bemühungen, die Reichweite von Bentrio auf dem Markt zu erweitern und verstärkt das Engagement für Qualität und regulatorische Konformität in der Medizintechnik.
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Hamilton, Bermuda, Sept. 27, 2024 (GLOBE NEWSWIRE) --
- Certification to ISO 13485 extended to also include production process
- Supports Bentrio growth strategy together with strategic contract manufacturer and expanding network of international distributors
Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO) today announced that its associate company Altamira Medica Ltd. obtained extended ISO 13485 certification for its quality management system, including henceforth also production activities. With this extension, the quality management system has been certified for the whole design, development, production and distribution cycle for Altamira Medica’s Bentrio® nasal spray.
“We are very proud of passing the required audits for the certification of our quality management system for Bentrio in accordance with the internationally recognized, rigorous ISO 13485 standard,” commented Thomas Meyer, Altamira Medica’s Chairman and CEO. “Our comprehensive and effective quality management system helps to ensure that Bentrio complies with high quality standards and regulatory requirements. Its extension to also include our production processes is an important milestone in our growth strategy for Bentrio, which we are implementing with a strategic contract manufacturer and an expanding network of international distributors.”
About Bentrio
Bentrio is an “over the counter” drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne particles with cells; in addition, the composition serves to bind such particles and help with their discharge. The efficacy and safety of Bentrio has been demonstrated in a total of four clinical trials, of which the largest one (“NASAR” study) enrolled 100 patients suffering from seasonal allergic rhinitis. In NASAR, participants self-administered either Bentrio or saline nasal spray for two weeks 3 times per day. The study showed a statistically significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) for Bentrio compared to saline (p = 0.013), as well as a statistically highly significant improvement in health-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire, p < 0.001) and superior global ratings of efficacy by patients and investigators alike (p < 0.001). In addition, Bentrio showed good safety and tolerability, similar to saline controls, and fewer Bentrio treated patients used relief medication and more of them enjoyed symptom-free days compared to saline treatment. For more information, visit: www.bentrio.com
About ISO 13485
ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device. Certification is achieved based on passing a thorough and comprehensive audit by an independent, accredited organization. ISO (International Organization for Standardization) is a worldwide federation of more than 160 national standards bodies.
About Altamira Therapeutics
Altamira Therapeutics (Nasdaq: CYTO) is developing and supplying peptide-based nanoparticle technologies for efficient RNA delivery to extrahepatic tissues (OligoPhore™ / SemaPhore™ platforms). The Company currently has two flagship siRNA programs using its proprietary delivery technology: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. The versatile delivery platform is also suited for mRNA and other RNA modalities and made available to pharma or biotech companies through out-licensing. In addition, Altamira holds a
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