Category: Pharma | Tentamus

Analyst Launches Q&C Plan to Support Young Israeli Start-Ups

Under the Quick & Clean (Q&C) Plan, Analyst Research Laboratories enables early-stage Israeli life-science companies to gain access to state of the art equipment and staff. Thus, even feasibility studies can be performed on qualified and highly reliable equipment with highly-trained staff, enabling companies to make more reliable Go/No Go decisions. Frequently, young start-up companies

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TentaMedix extends its GMP portfolio

Pyrogen testing methods have been successfully inspected by the Regierungspräsidium Tübingen as GMP compliant (Regional Council Tübingen) TentaMedix GmbH is pleased to announce the extension of its GMP relevant testing portfolio. Already in the year 2019, TentaMedix GmbH received the official certificate of recognition from the ZLG and the listing as an officially recognised

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Tentamus Pharma & Med Webinar Series 2020

In times of COVID-19 we are offering our clients an opportunity to stay connected and informed from the convenience of your labs, homes, or offices. Attend our webinars the weeks of 26th October 2020 until 06th November 2020. Participate in our webinars, where you’ll get access to expert know-how. Our experts are specialists in their

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COVID-19: FDA introduces new risk assessment system for inspections

The U.S. Food & Drug Administration (FDA) is preparing to resume domestic inspections with a new risk assessment system. Due to the corona pandemic, restrictions have been in place since March. In order to continue to bring safe products onto the market or to monitor them on a risk-based and qualitative basis, guidelines and processes

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COVID-19: How Robust is your Pharmaceutical Supply Chain?

2020 will be remembered for a long time as a time that changed our personal and professional lives. From R&D through manufacturing to distribution, the pandemic is impacting the pharmaceutical sector. The industry has been invigorated in recent months but is also being compromised, most notably through supply chain disruption. Even as in-country restrictions are

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Renolab is extending its certification

In vitro pharmacodynamics (PD) for human use drugs with anti-infectious activity Starting from 2019, the microbiology department at Renolab is extending its certification, thus continuing the providing of pharmacodynamics (PD) services based on the relationship between the properties of new drugs and bactericidal, fungicidal and virucidal effects. The tests will be conducted following the

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Microbiological Services at VelaLabs Facilities fully operational in July

Vienna, May 2020: Last year in June, VelaLabs, part of the Tentamus Pharma division, acquired the pharmaceutical test laboratory “Laboratorium für Betriebshygiene GmbH” (LABH). LABH is focusing on microbiological services such as sterility testing in accordance with Ph. Eur. requirements as well as environmental control and germ identification. Consulting in these areas is also part

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Changes in the (pharma) world during the COVID-19 pandemic

The pharmaceutical industry is subject to constant change. In the last decade, the production of raw materials and active ingredients in particular has increasingly been relocated to countries where production can be carried out in a more cost-effective manner. Outsourcing to external contract manufacturers, so-called “Contract Manufacturing Organizations” (CMO), has become increasingly popular. However, the

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New limits for nitrosamines from 2021

Nitrosamines are found in cosmetics, pesticides, tobacco products, and most rubber products. These chemical compounds are formed when nitrites and amines come into contact with acid (e.g. stomach acid) or during production of e.g. pharmaceuticals. Another possibility is the release from the breakdown of specific organic substances. High temperatures encourage the growth of nitrosamines (e.g.

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Product analytics & market release of hydroxy-chloroquine & chloroquine

Speculation is ongoing that a decade-old malaria drug may be one of the key medications slowing down the spread of the novel coronavirus (COVID-19). This dedicated drug is comprised of the chemical chloroquine. Although these chemicals are not legislatively approved to treat COVID-19, an off-label use is in discussion. Recent studies suggest that chloroquine is

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