Symbiotic Research: Determination of Nitrosamine Impurities as Chemical Contaminants in GMP Drug Product-Metformin

International Trade Center, Mount Olive, New Jersey–SYMBIOTIC RESEARCH, LLC (SRL), a Tentamus Company, announces a multi-residue screening and quantitative UPLC-APCI-HRMS method developed for several targeted Nitrosamine impurities as chemical cross-contaminants in manufactured drug product Metformin. The HRMS component utilizes Time of Flight (TOF) mass spectrometry. The U.S. FDA recommends drug manufacturers to monitor specific drugs […]

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Wechsel in der Geschäftsführung beim BAV Institut GmbH

Seit dem 01.01.2023 wurde die Geschäftsführung beim BAV INSTITUT neu aufgestellt und an bewährte, langjährige Mitarbeiter:innen übertragen. Als Paul und Iris Andrei das Unternehmen 1997 gegründet haben, hatten sie keine umfangreichen Business-Pläne, aber gute Ideen und eine Vision. Sie wollten den Kunden beste Labordienstleistungen anbieten und für die Mitarbeiter:innen ein attraktiver Arbeitgeber sein. Da die […]

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Analyst Reports Successful GMP FDA Audit with No 483s

The FDA informed Analyst Research Laboratories, that following an inspection performed at Analyst, it has determined that the company is in compliance with regards to current good manufacturing practice (CGMP). During November, 2022, the US Food and Drug Administration (FDA) performed an on-site inspection at Analyst’s facilities in Ness Ziona, Israel. Following this inspection, the […]

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Tentamus Green Line – ein grüner Service der Tentamus Group

Die Tentamus Group, ein globales Netzwerk von hochspezialisierten Laboren im Life-Science Bereich, hat mit Tentamus Green Line – Sustainable Services & Solutions ihre bestehenden Services weiterentwickelt – hin zu einem nachhaltigen Geschäftsbereich. Tentamus Green Line hat das Ziel Produktsicherheit und Transparenz entlang der gesamten Lieferkette zu erhalten. Den Kunden der Tentamus Group bzw. ihrer Standorte […]

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Tentamus Green Line – A green service line of the Tentamus Group

The Tentamus Group, a global network of highly specialized laboratories in the life science sector, has further developed its existing services with Tentamus Green Line – Sustainable Services & Solutions – towards a sustainable business unit. Tentamus Green Line aims to maintain product safety and transparency along the entire supply chain. Customers of the Tentamus […]

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Tentamus Group forms strategic alliance with Warrantek

Tentamus Group and Warrantek are delighted to officially announce their strategic partnership and alliance. Effective immediately, the two companies will work closely together to promote joint development in Southeast Asia. Warrantek is a recognized service provider in the field of food safety, analytical testing, and consulting. Based in Can Tho City (headquarter) and Tan Binh […]

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One Broth One Plate Salmonella Method – Addition to UKAS Testing Schedule

Southern Microbiological Services (SMS Ltd.) has been offering UKAS accredited microbiological testing services to the food and drinks industries since it was established in 1989. Located near Wellington, Somerset, in the UK, SMS Labs is excited to announce the addition of a new Salmonella method, to its UKAS Schedule of Accreditation. Sally Bellekom, Director of […]

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ISEMED and Arazy Group sign agreement for advanced regulatory affair technology

Global market access is now available to the Italian Medtech and IVD industry using advanced regulatory affair technology and management platforms. ISEMED (Imola, Italy) had signed a representation agreement with Arazy Group Consultant (Vancouver, BC, Canada) to become the Italian representative of Arazy’s advance regularly affair technology, SaaS system, and software specifically designed for medical […]

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