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Drug Administration Services
50 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) ...
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) ...
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: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 ...
by:Kalium Solutions based inBoucherville, QUEBEC (CANADA)
We can obtain for you a Natural Product Number (NPN) as well as a site licensing (SL) by Health Canada for your ethyl or isopropyl alcohol-based hand sanitizers. We can also get its US equivalent, a registration number (NDC registration number) from the Food and Drug Administration ...
Manufactured by:Hitec Medical Co., Ltd. based inShanghai, CHINA
Hitec Medical is a professional manufacturer and distributor of medical disposables mainly in Respiratory, Urology, Anesthesiology and Pain management systems. Hitec follows all relevant China Food and Drug Administration guidelines, and is an ISO 13485 registered company. All Hitec product systems are CE ...
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 ...
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 ...
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: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 ...
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 ...
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)
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. ...
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: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:Soteria Medical BV based inArnhem, NETHERLANDS
Prostate cancer incidence rates rose dramatically in the late 1980s, when screening with the prostate-specific antigen (PSA) test, which received initial U.S. Food and Drug Administration approval in 1986, came into wide use. It is estimated that approximately $9.9 billion is spent each year in the United States on prostate cancer treatment. (National Cancer ...
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 ...