Drug Application Services
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Manufactured by Creative Biolabsbased in CHINA
Custom tailored thermal shift assay services with several applications of drug discovery. ...
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based in USA
Investigational New Drug Applications’ toxicity studies, associated non-clinical safety studies, and biological activity programs to support clinical investigations and marketing authorization. Clinical Regulatory Support – Develop clinical investigations to establish safety, proof-of-concept, and efficacy sufficient to support ...
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Manufactured by Ascendia Pharmaceuticalsbased in USA
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness ...
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Manufactured by OnLume Inc.based in USA
OnLume Surgical’s novel approach to fluorescence-guided surgery provides superior imaging with high sensitivity allowing low fluorescent drug concentrations – even under ambient OR light conditions. And, our imaging device is adaptable and applicable to a broad spectrum of targeted fluorescent drugs for applications ...
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Manufactured by ClearLight Biotechnologies, Inc.based in USA
Long before your team will experience commercial success with your brand name drug, preclinical drug development activities take center stage. By the time you submit your investigational new drug (IND) application you’ll want to retire as many risks as possible and have confidence that your experimental ...
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by Ergomedbased in UNITED KINGDOM
Global regulatory framework assessment tool. This heat-map assesses the suitability of the country's regulatory framework based on your protocol. Simply enter details of your trial design to see which countries will facilitate fast approval and which ones will be more challenging. The fastest countries will be colored the darkest, more challenging the lightest and white where it's not possible. ...
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by Vetterbased in GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
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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
Strategic regulatory planning and implementation is a critical component of any product development program. Understanding the regulatory pathway up front not only allows for clarity in the development process but can also save valuable time and ...
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Manufactured by Piramal Pharma Solutions (PPS)based in INDIA
Piramal’s regulatory team, provides expert clinical & regulatory support through all phases of drug development. This includes regulatory support on New Chemical Entity’s (NCE), Clinical Trials, Marketing products, Generics, OTC ...
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by OHS Inc.based in USA
Employee drug testing works! Since 1988, “The Drug Testing Index”™ report by Quest Diagnostics Laboratories has been updated and released annually. Their most recent report is based on more than 10 million drug tests of USDOT-regulated, "safety-sensitive", and "general workforce" employees performed during 2021. The ...
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based in USA
From early strategy discussions and meetings with agencies to submissions and applications support on through commercialization, we help our clients with regulatory, compliance, validations, training, and auditing support. Our understanding of domestic and international biotech and pharmaceutical operations and of the regulatory challenges ...
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based in USA
At Cytotheryx, we understand that life-saving discovery in liver disease research and medicine requires a multi-faceted approach. The key to enabling this innovation is a reliable foundation. We understand this need and the opportunity to support numerous areas working to advance human health—this is our sole ...
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Manufactured by AnaBios Corporationbased in USA
EX VIVO Human Platforms for Cardiovascular Drug Discovery. Broadly defined, cardiovascular disease is the leading cause of death for men and women across most racial and ethnic groups in the United States with one person dying approximately every 34 seconds1. To drive successful clinical translation of new cardiovascular medicine, AnaBios ...
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based in USA
After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise clinical report writing. Such clear and precise clinical writing aids reviewers to easily comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing delays ...
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Manufactured by BTG International Inc.based in USA
We believe in the transformative power of medical innovation to improve human health. We set out to establish the safety and efficacy of our products, but also to improve standards of care. Ultimately, we want to help physicians better care for their patients. Take for example our prospective study to demonstrate the benefit of early treatment of copperhead envenomation. Our research also aims to ...
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Manufactured by Firalis Groupbased in FRANCE
The successful implementation of a biomarker endpoint is highly dependent on the availability of assays and on reliable measurements of markers in biological samples. While a large number of assays are on the market, scientists often have an urgent need for assays meeting specific ...
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based in USA
With more than 20 years of experience in pharmaceutical research and manufacturing, we understand the specific challenges aseptic fill-finish and manufacturing presents. Our facility is carefully designed with the flow of personnel and materials in mind, which follows current Good Manufacturing Practices (cGMP) guidelines and minimizes contamination or mix-ups. Flexibility is important during ...
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Manufactured by Creative BioMartbased in USA
Creative Biomart provides drug analysis service for pre-clinical drugs and natural products on their physical and chemical properties. Our services include three main assays: pre-clinical pharmaceutical property analysis, pharmacokinetics analysis & bioanalysis, andnatural product ...
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Manufactured by MedGenome Inc.based in USA
Profiling the Tumor Microenvironment: Using a genomics based approach to analyze the tumor microenvironment can provide unique insights beyond IHC and FACS methods. OncoPeptTUME deeply interrogates RNA-Seq data sets to produce high resolution mapping of the tumor microenvironment using proprietary cell type specific gene expression signatures. OncoPeptTUME provides a critical assessment of the ...
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