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Emas Services Available In Kuwait
17 services found
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:AGC Biologics based inBothell, WASHINGTON (USA)
AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have ...
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 ...
Manufactured by:Asahi Kasei Bioprocess based inGlenview, ILLINOIS (USA)
Audit reports for Planova™ Plant and Planova™ Oita Plant are now available for purchase from Rx-360, an international pharmaceutical supply chain consortium. Purchasing these audit reports allows biopharmaceutical companies to obtain audit reports for Planova™ manufacturing facilities without having to conduct the audits directly, which could potentially help to save time and ...
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:Cytel based inWaltham, MASSACHUSETTS (USA)
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to optimize the speed, savings and probability of success of their clinical trials. Cytel's statistical consultants and data managers work in tandem with sponsors to ensure new medicines move forward with the right study ...
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. ...
Manufactured by:Avania based inBrunswick, AUSTRALIA
Avania clinical safety management specializes in the distillation and dissemination of the information you need to design an efficient program and bring your product to ...
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 ...
Manufactured by:Piramal Pharma Solutions (PPS) based inMumbai, INDIA
We offer specialized services in clinical trial supply management using a global network of assets, experience, and expertise in streamlining the clinical trial packaging and supply process, thereby ensuring that the study drug is available as ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
Including Pharmacokinetics and Immunogenicity. Designed to be an extension of your laboratory, Nexelis, a Q² Solutions Company, supports bioanalysis in all phases with agile assay development to validation mindset. Whether we design a custom bioanalytical assay or support a client’s technology transfer, our method development process results in an optimized assay compliant with global ...