Drug Administration Services
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Manufactured by Recipharm ABbased in 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) ...
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Manufactured by Integer Holdings Corporationbased in 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 ...
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by Solvias AGbased in SWITZERLAND
Solvias has a track record over several years in supporting the cGMP analysis of biosimilars (European terminology) or follow-on biologics/follow-on protein products (terminology of the US Food and Drug ...
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based in 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 ...
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based in 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) ...
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Manufactured by Atrion Corporationbased in 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 ...
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Manufactured by Hitec Medical Co., Ltd.based in 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 ...
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by ItemTrackerbased in UNITED KINGDOM
The requirement to validate software is an ever increasing one and is spreading to activities that support the manufacture of Pharmaceutical, Medical Device and Biotech industries. The US FDA (Food and Drug Administration) recently re-issued its guidance on Computerised Systems Used in Clinical Investigations (May 2007) which ...
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Manufactured by AGC Biologicsbased in 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 ...
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based in 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 ...
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based in 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 ...
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Manufactured by Emmaus Medical, Incbased in USA
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. ...
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Manufactured by MorphoSys AGbased in GERMANY
Expanded Access to our Investigational Medicinal Products Policy. 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 ...
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Manufactured by Ascendia Pharmaceuticalsbased in 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. ...
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based in 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 ...
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based in 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. Navigating the medical device regulation ...
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by Morgan Lewisbased in USA
issues through IP protection; U.S. Food and Drug Administration (FDA) and other regulatory approvals and Centers for Medicare and Medicaid Services pricing and reimbursement, marketing and distribution; to litigation and counseling in all relevant areas, including fraud and abuse, compliance programs, product liability, IP, and labor; as ...
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Manufactured by Ascendia Pharmaceuticalsbased in 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 ...
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Manufactured by Alfa Chemistrybased in USA
and Drug Administration (FDA) has approved ifosfamide only for testicular cancer. A study analyzed the therapy outcomes of 39 patients with testicular cancer who were treated with ifosfamide as a monotherapy from 1970-1977. The results showed that 16/39 patients (41%) were tumor-free after chemotherapy and operation and 6 of them survived for more than ...
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Manufactured by Soteria Medical BVbased in NETHERLANDS
Prostate cancer is the most common cancer, other than non-melanoma skin cancer, and the second leading cause of cancer-related death in men in the United States. 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 ...
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