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Method Validation Services In Europe
19 services found
Manufactured by:Recipharm AB based inStockholm, SWEDEN
We provide analytical validation in compliance with the European Pharmacopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) ...
Manufactured by:RTI Surgical based inAlachua, FLORIDA (USA)
We provide an additional measure of safety by adhering to strict donor screening criteria and tissue preparation methods validated to address potential disease ...
Manufactured by:BCN Peptides S.A. based inSant Quintí de Mediona, SPAIN
Throughout the development and industrial lifecycle of all our APIs, we provide analytical support to contracted customers as required for cGMP compliance. We have extensive analytical expertise and offer all analytical services to ensure successful product development. Our vast platform of state-of-the-art analytical techniques is designed to meet all regulatory requirements for our products ...
Manufactured by:Recipharm AB based inStockholm, SWEDEN
The flexibility, capacity and expertise to take care of your analytical requirements. At Recipharm,?our analytical experts are here to help you rapidly develop your molecule to successfully bring it to the clinical stage and ...
Manufactured by:Applied Pharma Research s.a. based inBalerna, SWITZERLAND
Pre-formulation development: physical and chemical characteristics of the proposed drug are analyzed to allow selection of optimal excipients and dosage forms. Formulation design: based on the product's physicochemical/release characteristics and other important aspects, a range of theoretical formulations is proposed to determine how they affect the final product's characteristics such as in ...
by:Gesellschaft für Bioanalytik Hamburg mbH(GBA) based inHamburg, GERMANY
In January 2012, LAT GmbH Dr. Tittel Institute for Pharmaceutical Analysis joined the GBA Laboratory Group along with its site in Gräfelfing, Bavaria. LAT GmbH offers comprehensive capabilities in the field of pharmaceutical analysis and is specialized in the following ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
To ensure we provide the best possible service to you, Minaris Regenerative Medicine and our cell & gene therapy specialists offer guidance at every stage of your process. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
The analytical aspects of pharmaceutical development are demanding, as in contrast to pure drug substances, matrix effects need to be taken into account. As one of the most skilled and experienced companies in the field of pharmaceutical development analytics, we can meet your ...
Distributed by:KRSS Europe B.V. based inVeenendaal, NETHERLANDS
KRSS has set up a team of Clinical Application scientists with over 60 years’ experience working in clinical laboratories. This means we can now offer clinical application support at affordable prices as well as developing new automated methods in many clinical application areas which can then be offered to our CSP customers as part of their ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We provide rapid and comprehensive support for your early-phase drug development process, enabling you to establish 'critical mass' – in terms of personnel and know-how – in the chemical and analytical development of complex small-molecule ...
Manufactured by:Elos Medtech. based inRosenheim, GERMANY
Medical devices demand the highest degree of safety, functionality and efficiency. A well planned and performed validation program is the basis for a safe and efficient product and a successful product approval. puracon can support you not only in setting up a product-based validation program, but also in organizing and performing the selected validation program in-house or with expert partners. ...
Manufactured by:Heppe Medical Chitosan GmbH based inHalle (Saale), GERMANY
You need a chitosan or chitosan derivative for your medicinal product or drug or You are doing industrial research and development? Our products are particularly suitable for your ...
by:Eurofins Scientific based inKraainem, BELGIUM
Complete preclinical service: Early and full drug development is regulatory-driven and complex. The priority in this selection process is to achieve the safety and efficacy of a new molecular entity. The preclinical activity includes mainly safety and pharmacological testing accompanied by metabolism, bioanalysis, biomarker development and pharmaceutical analysis. Eurofins offers the whole panel ...
by:Emmace Consulting AB based inLund, SWEDEN
ISO 18562-4 addresses the critical need for quantifying and assessing the risks associated with condensate produced during patient use, which can potentially enter the lungs or the throat region depending on the device. Accurate measurement of the condensate volume is essential for ensuring patient safety, meeting regulatory requirements and making it possible to estimate the exposure to ...
by:Almac Group based inCraigavon, UNITED KINGDOM
Almac has extensive expertise in the development of biomarker assays for commercial partners across a wide range of ...
by:ALS Environmental based inHouston, TEXAS (USA)
At ALS our Pharmaceutical Division is a provider of testing services to the Pharmaceutical and Healthcare industries in Australia, Europe and Asia. Committed to exceeding customer expectations we are able to provide high quality solutions across a range products, including human and veterinary products, intermediates and raw materials. Testing is conducted according to international standards ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing process and validation methods used to evaluate the drug product performance must be accurate and ...
by:Biovian Oy based inTurku, FINLAND
Adenoviruses are attractive tools for gene therapy, including immuno-oncology, because of their well-defined biology and characteristics including the possibility for large gene inserts. Biovian has proven expertise in adenovirus vector process development, GMP production, and analytics. Since 2004, we have developed processes and have manufactured over 40 clinical adenovirus GMP batches for our ...
by:Fera Science Limited (Fera) based inYork, UNITED KINGDOM
End to end support for Endocrine Disruptor (ED) Assessment: Fera Science and Enviresearch have collaborated to offer clients an end to end assessment of the endocrine disruptor properties of their ...