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Drug Delivery Applications Services In Usa
19 services found
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 Biologics have helped us continuously ...
by:Latham BioPharm Group based inElkridge, MARYLAND (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 ...
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
Strategic Planning – Develop approval strategies including Chemistry Manufacturing and Controls (CMC) and non-clinical and clinical programs. FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical Regulatory Support – Manage Investigational New Drug Applications’ toxicity ...
by:OHS Inc. based inCosta Mesa, CALIFORNIA (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 success of employee drug testing has long-ago been confirmed! ...
Manufactured by:OnLume Inc. based inMadison, WISCONSIN (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 across the full range of surgical specialties. ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (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 reports on the drug product, but allows information required for ...
Manufactured by:AnaBios Corporation based inSan Diego, CALIFORNIA (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 develops relevant human ex vivo platforms for many ...
by:Cytotheryx, Inc. based inRochester, MINNESOTA (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 ...
by:Pace Analytical based inRoseville, MINNESOTA (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 facing these industries allows our experts to provide ...
Manufactured by:ClearLight Biotechnologies, Inc. based inMountain View, CALIFORNIA (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 drug will have its intended effects on the intended to treat population ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (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 ...
Manufactured by:BTG International Inc. based inConshohocken, PENNSYLVANIA (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 ...
by:Pace Analytical based inRoseville, MINNESOTA (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 ...
Manufactured by:Creative BioMart based in, NEW YORK (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 ...
Manufactured by:MedGenome Inc. based inCounty of New Castle, DELAWARE (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 ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Acute Radiation Syndrome (ARS) involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow makes victims vulnerable to life-threatening hemorrhage, infection and anemia. ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Antibody drug developability analysis (drugability analysis) is a key strategy used to evaluate the development prospect of candidate antibody drug. This analysis is based on a comprehensive evaluation of multiple aspects of the candidate antibody, including biological activity, pharmacology, pharmacokinetics, safety, and preparation feasibility. Through systematic developability analysis, ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Generic peptide pharmaceuticals are products that replicate existing peptide drugs. These drugs are typically composed of amino acids linked by peptide bonds and are used to treat a variety of diseases, including cancer, diabetes, and immune disorders. Developing these generics requires comprehensive research into synthesis processes, formulation technologies, quality control, and bioequivalence ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Peptides are compounds formed by multiple amino acids linked by peptide bonds and can be prepared via recombinant DNA expression, biological extraction, or chemical synthesis. Peptides represent a unique class of drugs with certain characteristics of small molecule drugs as well as properties of large proteins and other biologics. Most intrinsic signaling molecules are peptide-based, such as ...