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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 which are prone to contain nitrosamines as impurities. Nitrosamines in these drugs must be monitored and quantified by HRMS techniques, as opposed to conventional nominal mass LC-MS/MS systems. The US-FDA has already released its own high resolution full scan LC-MS quantitative method for screening such impurities: www.fda.gov/…. Dan Safarpour, Ph.D., CEO of SRL presented this…
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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 Arbeit Paul und Iris Andrei mit den Kunden und mit den Mitarbeitern:innen viel Freude bereitete, werden sie auch in Zukunft BAV treu bleiben und das Team unterstützen. Jetzt ist der richtige Moment gekommen die Geschäftsführung an zwei tolle Nachwuchskräfte zu übergeben. Julia Paustian und Reiner Schmider gehören bereits seit vielen Jahren zum BAV-Team. Sie sind…
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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 FDA informed Analyst it has determined that the inspection classification of this facility is "no action indicated" ("NAI") and that based on this inspection, Analyst is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP). Analyst’s CEO, Dr. Vivi Ziv commented: “We are all excited and honored…
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Environmental labeling of packaging: approaching the final deadline
Starting from 01/01/2023 new packaging produced in Italy shall be compliant with the Decree No. 116 of 3 September 2020, which is the Implementation of Directive (EU) 2018/851 on waste and Directive (EU) 2018/852 on packaging and packaging waste. The decree aims to guide the development of the so-called “Circular Economy Package” by making the labeling of packaging with useful information mandatory, both for identification and for the classification of the materials used. This will make it easier for the user to identify the correct waste collection, but also to make a critical choice for consumers who prefer greener packaging. The compulsory information required by the decree are: The identification…
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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 kann so ein Verständnis dafür vermittelt werden, welche Faktoren die größten schädlichen Auswirkungen auf unseren Planeten haben. Tentamus Green Line hat den Fokus auf Dienstleistungen in den Bereichen: Nachhaltige Dienstleistungen Nachhaltige Lösungen für Unternehmen Trends im Bereich Nachhaltigkeit Dr. Yvonne Pfeifer freut sich: „Wir bei Tentamus haben die Mission die Gesellschaft in eine sichere Zukunft…
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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 Group or its sites can thus be provided with an understanding of which factors have the greatest harmful impact on our planet. Sustainable services Sustainable solutions for companies Trends in sustainability Dr. Yvonne Pfeifer is pleased to say, “At Tentamus, our mission is to lead society towards a safer future for people and the environment.…
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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 Industrial Park, Ho Chi Minh City, Vietnam, Warrantek aims to provide its partners and customers with the best possible consulting and analytical support to bring high quality products to the market. Vinh Luong, Country Manager of Tentamus Vietnam is pleased and in high spirits about the cooperation:“Warrantek is a state-approved company and laboratory and is…
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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 SMS Ltd is delighted: “Following the successful introduction of One Broth One Plate Listeria method (OBOP-L), we were very keen to offer the Salmonella version to our clients. Neogen’s One Broth One Plate for Salmonella (OBOP-S) offers a rapid method for the enrichment and detection of Salmonella spp. using traditional culture methodology. Benefits include a…
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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 and IVD device manufacturers. Arazy Group Consultants Inc is a leading Medtech and IVD regulatory affairs firm with 26 years of experience. The company’s HQ is in Vancouver, BC, Canada, and it provides its services in over 140 counties worldwide. The company developed propriety regulatory affair technology, LICENSALE – Global MedTech Registration Management System, and…
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Anastasia Roehrig strengthens Tentamus Group as new CFO
The entire team of the Tentamus Group is delighted to introduce Anastasia Roehrig as their new Chief Financial Officer. With effect from October 1, 2022, Anastasia Roehrig is responsible for the finance department of the Tentamus Group and becomes a member of the global management board. Dr. Jochen P. Zoller, CEO & founder of the Tentamus Group commented: “Anastasia Roehrig joins us from various management positions in service industries. She brings her expertise as an accomplished financial and commercial expert, who complements our management team perfectly. With her dynamic approach and know-how, she is an excellent fit for us. We’re very much looking forward to working together in the future.”…
