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Companies Related to "Type DMFs CDER Combination Products Using Device Constituent" [Most Relevant Company Matches] RSS

13:15 EST 9th December 2019 | BioPortfolio

Here are the most relevant search results for "Type DMFs CDER Combination Products Using Device Constituent" found in our extensive corporate database of over 50,000 company records.

Showing "Type DMFs CDER Combination Products Using Device Constituent" Companies 1–25 of 7,700+

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Carbylan BioSurgery, Inc.

Carbylan (www.carbylan.com) was founded in 2005 to develop and market medical devices and device/drug combination products based on novel chemically engineered polymer systems incorporating hyaluronic acid, a well-known polysaccharide widely present in the human body. Its initial market focus is therapeutic medical devices and combination products to treat...


Product Quality Research Institute

The Product Quality Research Institute (PQRI) is a collaborative process involving FDA’s Center for Drug Evaluation and Research (CDER), Industry, and Academia. The mission of PQRI is to conduct research to generate specific scientific information that should be submitted in a regulatory filing to CDER. PQRI has been in development since January of 1996, guided by a Steering Committee composed o...

Convio, Inc.

Convio is a leading provider of on-demand constituent engagement solutions that enable nonprofit organizations to maximize the value of every relationship. With Convio constituent engagement solutions, nonprofits can more effectively raise funds, advocate for change and cultivate relationships with donors, activists, volunteers, event participants, alumni ...


Asahi Kasei Corporation

Asahi Kasei Corporation, with consolidated sales of US$10 billion, provides innovative solutions based in chemistry and materials science to a diverse range of markets including fibers, chemicals, consumer products, housing, construction, electronics, and health care. On October 1, 2003, all core operations were transferred to seven wholly owned constituent corporations as autonomous operating bus...

TYRX, Inc.

TYRX, Inc. commercializes innovative, implantable combination drug/device products focused on infection control including the AIGISRx® Antibacterial Envelope and AIGISRx® FS products. AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infection...

Zydus Pharmaceuticals (USA) Inc.

Zydus Pharmaceuticals (USA) Inc. is a globally integrated generic pharmaceutical company with a focus on providing high service, quality and affordable products. Our leadership, which has over 40 years of US generic market experience, understands our customer’s business which allows Zydus Pharmaceuticals the ability to provide unique models to help drive their success. Though a new company in th...

Baggerman

Investigational medicinal products (IMP’s) are on the agenda these months as we are to take care of the regulatory details of two such products. For an ophthalmological product we are co-writing parts of the Investigational Medicinal Product Dossier (IMPD). A second project includes a new radiopharmaceutical compound for which we have to comment on the supply chain. In addition we will support t...

Creative Peptides develops pharmaceutical products

Creative Peptides develops pharmaceutical products based on C-peptide Our research will significantly improve on the treatment of long-term complications of type 1 diabetes. Complications of type 1 diabetes are currently not effectively and safely treatable and cause great suffering in afflicted patients as well as vast costs to society

GeNO LLC

GeNO LLC, founded in 2006, is a privately held, advanced development-stage technology company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized. The company is focused on applying the new technology to deliver inhaled nitric oxide to patients in a wide variety of settings, including ambulatory and ...

Globaltel Media

Globaltel Media is the first company to provide true two-way text dialog with rich media from any PC to any mobile phone and back regardless of the wireless technology, wireless operator or wireless device. Globaltel Media connects online users with any mobile device regardless of location, technology, device type or cellular provider. Globaltel Media addresses the needs of customers across a rang...

Glucose Health, Inc.

Glucose Health, Inc. dietary products engage the large and growing market of consumers aware of the seriousness of Type 2 diabetes and proactively seeking natural blood sugar health solutions. The CDC currently estimates 2 in 5 adults – 86 million Americans – will develop Type 2 diabetes in their lifetime. Glucose Health, Inc. dietary products ar...

Hanmi Pharmaceutical co., Ltd.

Hanmi Pharmaceutical is a Korea-based pharmaceutical company. The Company invests over 20 percent of its sales in R&D and has over 20 programs consisting of the novel long acting biologics including weekly Insulin, weekly to monthly GLP-1, and their combination for diabetes and obesity (collectively referred as Quantum Project), the novel targeted anti-can...

DiObex

DiObex, Inc., a clinical-stage company based in San Francisco, is developing unique, first-in-class therapies for the critically under-served metabolic disease market. Our pipeline products address the markets for the treatment of type 1 diabetes, type 2 diabetes and its co-morbidities such as hypertension, dyslipidemia and visceral adiposity (often referred to collectively as “metabolic syndrom...

Veralox Therapeutics

VERALOX Therapeutics Inc. (https://veralox.com/) is developing first-in-class therapeutics that target the underlying pathologies of thrombosis and type 1 diabetes. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT) and HIT with thrombosis (HITT). Second generation therapeutic products are under development for ty...

Team Type 1 Foundation

Established in 2013, the Team Type 1 Foundation is a nonprofit organization pursuing a mission of education, empowerment and equal access to medicine for everyone affected by diabetes. Collaborating with governments, healthcare professionals, diabetes experts and individuals living with diabetes around the world, the Team Type 1 Foundation is bridging the ...

Bio Cardia.Inc.

BioCardia's Helical Infusion System enters the chambers of the heart from a blood vessel in the patient's leg. By physically attaching itself with a small hollow corkscrew needle to the wall of the beating heart, this catheter system provides improved control and ease of use to physicians. It is a two catheter system that includes the Morph deflectable guide catheter and the Helical Infusion Cathe...

Lakeland Industries

Our mission is to create and manufacture a wide variety of technologically advanced protective clothing that saves lives and protects workers both in private and public employment from fire, hazardous chemicals and diseases throughout the world. Among leading companies designing and manufacturing protective garments for industry, municipalities, and the burgeoning healthcare field, Lakeland Indu...

Medality Medical LLC

Medality Medical LLC, a privately funded (including an NIH grant) medical technology company, is focused on reversing type 2 diabetes and associated obesity. Its patented proprietary technology enables the gentle and selective extraction of excess mesenteric visceral fat, which has been associated with insulin resistance, a precursor to type 2 diabetes. In...

Leukocare AG

LEUKOCARE is a privately held clinical-stage biotechnology company founded in 2003 and headquartered in Martinsried/Munich, Germany. LEUKOCARE licenses proprietary technologies for stabilization and protection of proteins and other biologics against chemical and physical stress to partners in the fields of biopharmaceutical, medical device, and diagnostic industries. LEUKOCARE also offers know...

Tau Therapeutics LLC

Tau Therapeutics is a clinical stage company developing oncology drugs for solid tumors that selectively inhibit the T-type calcium channel – a novel mechanism of action for cancer. The company’s approach, called Interlaced Therapy™, capitalizes on the central role of calcium influx through T-type calcium channels during cancer cell growth. T-type ...

The T1D Exchange

The T1D Exchange is a unique platform for collaborative data collection and sharing that consists of three overlapping components: a clinic-based registry with clinical, biological and other real-life information from individuals with type 1 diabetes, a registry that is coordinated through a network of clinical centers and an interactive online community f...

CPC of America

We are engaged in the business of developing and/or acquiring cardiology therapeutic and disposable devices and products as well as the manufacturing and distributing of these devices and products for the diagnosis and treatment of coronary artery disease. To date, we have developed and/or acquired two products: the CPCA2000™ counterpulsation device and MedClose™, an internal puncture closing ...

Probably Relevant

Cavion LLC

Cavion LLC is a privately held clinical stage platform pharmaceutical company creating therapies engaging the T-type calcium channel (Cav3) for the treatment of neurologic and oncologic diseases. The T-type calcium channel is an emerging molecular target for cancer and pain.

Biologics Consulting Group, Inc.

The Biologics Consulting Group, Inc. (BCG) is a team of consultants who provide national and international regulatory and product development advice on the development and commercial production of biotechnological and biological products. Our staff consists of experts in regulatory affairs, product manufacturing and testing, pharmacology/toxicology, facility inspections, statistics, program manage...

T1D Exchange

T1D Exchange was founded on the belief that people affected by type 1 diabetes need better solutions faster – better treatments and better care. Our nonprofit organization takes an innovative approach that puts the community of people touched by type 1 diabetes at the center of research that will meaningfully impact their lives. Our integrated model ...


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