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Drug Administration Services In Usa
40 services found
Manufactured by:Integer Holdings Corporation based inPlano, TENNESSEE (USA)
Our commitment to quality ensures that our products and services meet or exceed the highest standards set by the United States Food and Drug Administration (FDA), the European Community, and other internationally recognized agencies. We maintain an industry-wide reputation as an award-winning manufacturer with high quality standards through enforcement of ...
by:Igenbio, Inc. based inChicago, ILLINOIS (USA)
Igenbio has provided support for both European Food Safety Authority (EFSA) and Food and Drug Administration (FDA) regulatory filing of Generally Recognized as Safe (GRAS) ...
by:German American Chamber of Commerce, Inc. based inNew York, NEW YORK (USA)
The German American Chamber of Commerce, Inc. in New York acts as U.S. Agent for German companies towards the U.S. Food and Drug Administration ...
Manufactured by:Atrion Corporation based inAllen, TEXAS (USA)
Atrion provides contract manufacturing services for other major original equipment manufacturers of medical devices. Our facilities are registered with the U. S. Food and Drug Administration. Our comprehensive services, including patent assistance and regulatory support, help our customers take their products from idea to ...
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 ...
Manufactured by:Emmaus Medical, Inc based inTorrance, CALIFORNIA (USA)
Under the terms of the agreement, Emmaus Life Sciences and Cellseed will conduct clinical trials to seek Food and Drug Administration approval for use by patients in the United States. ...
Manufactured by:MorphoSys AG based inPlanegg, GERMANY
At MorphoSys, our mission is to make innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Before these and all other investigational medicinal products can be made broadly available, the U.S. Food and Drug Administration (FDA) and other health authorities around the world require that they are investigated in clinical ...
by:Nexien BioPharma Inc. based inDenver, COLORADO (USA)
Nexien BioPharma is proceeding with pre-clinical and clinical drug development activities, in accordance with U.S. Food and Drug Administration ("FDA") protocols, for a number of pharmaceutical formulations that include ...
by:Igenbio, Inc. based inChicago, ILLINOIS (USA)
Igenbio has provided support for both European Food Safety Authority (EFSA) and Food and Drug Administration (FDA) regulatory filing of Generally Recognized as Safe (GRAS) organisms, including: Whole Genome Sequencing using both long and short read platforms available such as Illumina, PacBio, and Oxford Nanopore. Genome Assembly to EFSA and FDA completion ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. ...
by:in2being, LLC based inSaline, MICHIGAN (USA)
All medical devices in the United States are regulated by the Food & Drug Administration (FDA), and understanding the FDA’s definition of a medical device as well as how the agency classifies medical devices is a crucial part of learning how to bring your medical device to ...
by:in2being, LLC based inSaline, MICHIGAN (USA)
The Food and Drug Administration (FDA) regulates all medical devices in the United States to make sure they are safe and effective. These regulations are a critical part of the medical device development process, and they will likely influence the design and testing of new medical devices. ...
by:Morgan Lewis based inWashington D.C., WASHINGTON (USA)
Working on behalf of more than 1,100 clients, Morgan Lewis has the scale and scope of experience and capabilities to assist on all important aspects of our clients’ operations, from emerging business issues through IP protection; U.S. Food and Drug Administration (FDA) and other regulatory approvals and Centers for Medicare and Medicaid Services pricing and ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
Ifosfamide has been effectively employed in the treatment of multiple cancers, including testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, non-Hodgkin lymphoma, Hodgkin lymphoma, epithelial ovarian cancer, cervical carcinoma and germ cell carcinoma of the ovary[1]. Among all these cancers, the Food and Drug ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. Successful formulation development can determine ...
by:German American Chamber of Commerce, Inc. based inNew York, NEW YORK (USA)
German companies planning a US Market Entry are often confronted with numerous legal, tax and economic challenges. One of the most common reasons for a US Market Entry to fail is often not the business idea or the product itself but a lack of information and diligence when it comes to implementation. A successful US Market Entry requires therefore special planning to avoid the possible ...
Manufactured by:Laxxon Medical based inNew York, NEW YORK (USA)
Through our proprietary SPID®-Technology, we can repurpose, reposition, and relaunch generic APIs with patent protection while also addressing common issues with generic drugs such as patient compliance, dosage, and side effects. Our Advanced Patented Generics are going to be registered in the US under the FDA Section 505(b)(2), a fast-tracked regulatory approval process. In the EU, our ...
by:HDR Inc. based inOmaha, NEBRASKA (USA)
Our architects, engineers, designers and planners are inspired by our clients and their work. We are honored to design facilities where scientists may someday discover a cure for cancer, where caregivers provide a healing environment for injured U.S. soldiers returning from deployment, and where the fundamental acts of the United States Judicial System are demonstrated in real life each ...
by:Cyrus Biotechnology Inc. based inSeattle, WASHINGTON (USA)
Protein design has evolved tremendously over the last 20 years and Rosetta has been at the bleeding edge throughout that time. Rosetta was first at most major protein design achievements, such as protein stabilization, affinity, enzyme specificity, novel protein assemblies, and even entirely new protein structures with no sequence similarity to natural ...
by:Asbestos.com, The Asbestos & Mesothelioma Center based inOrlando, FLORIDA (USA)
It took nearly a century of research for doctors to learn what causes this cancer, who is most at risk for contracting it, what symptoms indicate its presence and what tools are most effective at diagnosing it. These strides significantly impacted how medical professionals treat asbestos cancer, but the investigation is hardly finished. Current efforts on developing more effective treatments and ...