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DSI-pharm – Your Partner for Pharmaceutical Analyses!

Analytical and Regulatory Consulting at DSI-pharm, laboratory for pharmeceutical analysis

Analytical and Regulatory Consulting

Analysis of Medicinal Cannabis at DSI-pharm, laboratory for pharmaceutical analysis

Analysis of Medicinal Cannabis

Stability Testing at DSI-pharm, laboratory for pharmaceutical analysis

Stability Testing

Laboratory Equipment at DSI-pharm, laboratory for pharmaceutical analysis

Laboratory Equipment

Batch Release Testing and EU Re-tests at DSI-pharm, laboratory for pharmaceutical analysis

Batch Release Testing and EU Re-tests

Method Development and Method Validation and DSI-pharm, laboratory for pharmaceutical analysis

Method Development and Method Validation

DSI-pharm – a Tentamus company

As a GMP certified laboratory we support our clients in regards of pharmaceutical quality control quickly, reliably and without complications. As a partner of pharmaceutical industry DSI-pharm shoulders responsibility for R&D projects and operates as an extension of our clients’ quality control (QC) workbench. Needs based, efficient, and with short turnaround times – since 1995.

Our Services – Your benefit:

  • Analytical consulting
  • Method development and method validation
  • Stability testing
  • Batch release testing and EU re-tests

Analytics and consulting

At the GMP-certified pharmaceutical laboratory, medicinal and related products, such as food supplements and medical devices, are tested by applying modern instrumental analyses. These include chromatography (UHPLC, HPLC, IC HS-/GC, DC) as well as pharmacopoeia-specified tests. The contract laboratory offers a combination of

  •  well-researched analytical and regulatory consulting,
  • project management and
  • practical lab work.

DSI-pharm knows the legal requirements and how authorities interpret them in day-to-day business. This allows development of economical, targeted pharmaceutical analytics for every product.

Laboratory with narcotics licence and manufacturing authorisation

The GMP laboratory sets the highest standards for operations, as verified by the GMP certification. In addition to this, DSI-pharm has been granted a licence pursuant to section 3 of the German Narcotic Drugs Act as well as a manufacturing authorisation for testing and batch release in accordance with Directive 2001/83/EC. The pharmaceutical laboratory provides QP-certified batch release testing to assist qualified persons in the process of batch release. Excellent services at a fair price – for DSI-pharm, this is all in a day’s work.

News

New efficacy test for veterinary disinfectants

Laboratorio Control, a reference partner of numerous companies for the analysis of biocidal products, implements a new efficacy test for disinfectants used on the skin in the veterinary industry.   > NEW PHASE 2,2 SKIN TEST FOR VETERINARY INDUSTRY (PT3). PR standard NF EN 17422:2019. The launch of this new quantitative surface efficacy test focuses ... Continued

In which foods are furan and its methyl analogs present?

In a recent recommendation, the European Commission calls for the determination of furan and methylfurans. These are process contaminants that form in food during thermal treatment. Consumers ingest furan particularly through coffee and cereal-based foods, but young children are also exposed to furan through jarred or canned ready-to-eat foods. According to the European Food Safety ... Continued

Laboratorio Control expands ENAC scope in food and animal feed

Laboratorio Control continues with its work plan focused on offering a wide range of analytical services under ENAC accreditation.   On this occasion, Laboratorio Control expands the ENAC scope in food and feed with the accreditation of mould and yeast count by culture according to ISO 21527-1 and 21527-2. Moulds and yeasts are one of ... Continued

Adalimumab - blockbuster & never ending story

Resolved patent disputes With Abbvie and Alvotech having solved their patent disputes, market entry for new biosimilars for adalimumab applicable for various indications might speed up. The patent protection of the originator product  Humira ® has expired in the EU in 2017, though due to complex patent claim development and market launch of non-component material ... Continued

Shock for manufacturer of substance-based medical devices

Long awaited, widely feared and stunningly received: The newly published MDCG document 2022-05 poses already suspected and yet very considerable challenges to medical device manufacturers of substance-based medical devices. While the Medical Device Regulation (MDR) 2017 still supported and thus legitimised this type of medical device with the official designation of “substances and combinations of ... Continued

Available NOW: Metals speciation for Inorganic Arsenic

There are two different forms of arsenic: organic and inorganic- and Columbia Labs tests for both. Inorganic arsenic is highly toxic and is therefore a public health concern; the organic form (commonly found in fish and seafood) is less harmful. The main source of exposure to inorganic arsenic is food; particularly grain-based processed products such ... Continued

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