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Emas Services In North America
10 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 ...
Manufactured by:Locus Biosciences, Inc. based inMorrisville, NORTH CAROLINA (USA)
With an eye on servicing healthcare markets globally, we built a 10,000 sq ft modular facility that can meet the standards of the US (FDA), Europe (EMA), Japan (PMDA), and several other countries and regions. The architectural layout and HVAC design ensure the robust biocontainment of organisms within the BSL-2 facility that meet all CDC, NIH, WHO, and ECDC requirements. At the ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
We render End to End Medical device MDR compliance and Regulatory services, Clinical trial, Pharmacovigilance services to Medical Devices industry. Our Medical Device team has extensive experience in working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW, regulatory Submissions and ...
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 ...
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 ...
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: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 ...