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Emas Services In Europe
17 services found
by:BioConnection based inOss, NETHERLANDS
BioConnection offers access to state-of-the-art GMP manufacturing facilities and a broad range of support services. BioConnection operates from its proprietary FDA and EMA approved facility in Oss, the Netherlands. From this facility, we can provide you with clinical scale manufacturing in a wide variety of formats and techniques, including freeze-drying. Besides our expertise in ...
Manufactured by:Quantificare Inc. based inSuwanee, GEORGIA (US) (USA)
We have developed both internal SOPs and adhere to world class regulatory standards which are in accordance to FDA 21CFR Part 11, EMA and other national regulatory . ...
Manufactured by:Quantificare Inc. based inSuwanee, GEORGIA (US) (USA)
When combined with our advanced image analysis capabilities, we can provide endpoint support and analysis for all study phases. Our imaging data is generated in a validated format conformant with FDA, EMA and other regulatory authority requirements. ...
Manufactured by:Fab’entech based inLyon, FRANCE
Fab’entech has notably developed a product against the H5N1 avian influenza (Fabenflu) and a product against Ebola under the aegis of the World Health Organisation (WHO) and with the support of the European Medicines Agency (EMA). More recently, Fab’entech has been heavily mobilised on the development and production of an anti-SARS-CoV2 treatment, the FabenCOV, which ...
by:Selvita S.A. based inKrakow, POLAND
These studies should be comparative in nature and should be designed to have appropriate sensitivity to detect relevant differences in the response to the similar biological medicinal product and the reference medicinal product. The scope of assays is in line with EMA guidelines (Guideline on non-clinical and clinical development of similar biological medicinal products ...
Manufactured by:ProBioGen AG based inBerlin, GERMANY
Customer satisfaction is at the heart of our quality management system (QMS), which assures products and services of utmost quality. We place the highest priority on product integrity, safe GMP manufacturing, and regulatory compliance (EMA, FDA, ICH). Our best-in-class QMS is founded on state-of-the-art technologies for manufacturing and testing. It is operated by a highly ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU. Our services include the following devices: Medical devices (and accessories), In-vitro diagnostic devices (and accessories), Wellness / ...
by:OracleBio based inGlasgow, UNITED KINGDOM
Studies conducted in accordance with this standard provides assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible (EMA Website). For quantitative image analysis data to be included in a data package submitted to regulatory authorities, it is essential that it is generated using a workflow that is in accordance ...
Manufactured by:Invicro, LLC based inNeedham, MASSACHUSETTS (USA)
A PSMA-PET scan is a powerful molecular imaging technique that can accurately localize prostate cancer and assess the level of a tumor’s PSMA expression. There are currently two USFDA and one EMA-approved PSMA-PET agents that are widely used in both clinic and trials. In early 2022, the USFDA approved the first targeted radioligand therapy, 177Lu-PSMA-61, for use in men ...
by:BioConnection based inOss, NETHERLANDS
Freeze drying brings stability and is therefore becoming increasingly popular. At BioConnection, we have many years of experience in the freeze-drying of sterile medicines. We offer freeze drying services for small or larger scale badges. ...
Manufactured by:CELONIC Group based inBasel, SWITZERLAND
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling batches, our scientists are highly experienced in keeping ...
Manufactured by:Aposcience AG based inVienna, AUSTRIA
In order to be tested in patients, APO-1 (APOSECTM) and APO-2 (APOSECTM) need to be manufactured under extremely strict quality standards following the principles of Good Manufacturing Practice (GMP) prescribed by regulatory agencies worldwide. Aposcience AG works closely together with the Blood Donation Service of the Upper Austria Red Cross in Linz (Primarius Dr. Christian Gabriel, ...
by:International Drug Development Institute (IDDI) based inLouvain-la-Neuve, BELGIUM
Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes. ...
by:BioConnection based inOss, NETHERLANDS
BioConnection offers clinical fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials, prefilled syringes or blowfill seals. Fill and finish is the core of our ...
by:BioConnection based inOss, NETHERLANDS
BioConnection offers commercial fill and finish for your products. Our capabilities include liquid fill or lyophilization intended for vials, prefilled syringes or blowfill seals. Our large scale state-of-the-art fill and finish line enables you to scale up to commercial production in time for the market. ...
by:International Drug Development Institute (IDDI) based inLouvain-la-Neuve, BELGIUM
Biostatistics Services is IDDI’s DNA and Core CompetenceAdvanced Statistical Methodology and Operational Excellence for Leaner and Faster Clinical Trials. Biostatistics is at the heart of every clinical study, driving study design, protocol development, clinical data collection, data analysis, and reporting. IDDI delivers optimal study designs, best practice randomization methods, regular ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
At Catalent, our methodologies work toward reducing the overall costs and time it takes to get your product to the clinic. With decades of experience in analytical development, we understand our clients’ needs, the current regulatory environment, and have a history of the development and qualification of analytical methods. We operate with a forward-looking methodology by deploying robust ...