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Drug Safety Services In Usa
16 services found
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
Alfa Chemistry has established a drug safety evaluation system that meets international standards. Our experimental studies strictly follow ICH, CFDA, FDA and OECD guidelines, providing our clients with high quality data and fast study cycles for preclinical safety evaluation of drugs. alfa chemistry helps our clients to shorten ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
The detection of microbial limit is one of the important measures to ensure its quality and drug safety. T,C&A Lab runs strictly in accordance with GMP and GLP standards to meet the relevant requirements of compliance, quality, efficiency, etc. We can perform microbiology testing according to USP , and . Welcome to contact our experts for consultation. ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
The Main Objectives of Conducting Forced Degradation Tests Include: Resolve the degradation products and determine the degradation pathway and mechanism of the drug. Help the development of API processes, formulation prescriptions and processes, and to help the screening of drug salts and crystalline forms. Provide support for drug ...
Manufactured by:Charles River based inHollister, CALIFORNIA (USA)
From complete IND-enabling programs to stand-alone assessments, our Safety Assessment team provides a full range of in vivo and in vitro testing services and regulatory support to comply with worldwide regulatory restrictions for the nonclinical development of pharmaceuticals, medical devices and animal health products as well as chemicals, agrochemicals, and biocides. Our ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
The development of antibody therapies has evolved from early polyclonal sera to monoclonal antibodies, and now to genetically engineered antibodies, focusing on enhancing drug safety, effectiveness, and manufacturing ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
In order to ensure the safety of drug product quality, the packaging system that comes into direct contact with the drug product needs to meet compatibility requirements. Compatibility studies refer to the process of evaluating packaging components or systems that are in direct contact with the drug product without serious, or ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Water vapor transmission capacity refers to the amount of water vapor through the specimen in a certain period of time under the specified temperature, relative humidity, and certain water vapor pressure. The main role of the drug bottle is to protect the safety of drugs in the process of storage and transportation, to ensure the stability of the ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ICH guidelines. ...
Manufactured by:Actylis based inPort Washington, NEW YORK (USA)
We develop sourcing solutions aiming not only at securing your access to strategic ingredients, but also to ensure the ingredients are produced sustainably with the highest guarantee of purity and traceability. For this we rely on a 70 years track record of supply chain integrity and an effective presence in many countries. Our global presence, R&D centers of excellence, and our strategically ...
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 ...
Manufactured by:AnaBios Corporation based inSan Diego, CALIFORNIA (USA)
CardioPRIME® is the AnaBios approach for measuring human cardiomyocyte functionality and sets the industry standard for cardiac-based biomedical research. By leveraging the robust excitation-contraction coupling of mature primary human cardiomyocytes and direct measurements of sarcomeric length, CardioPRIME offers unprecedented insight into cardiomyocyte functionality and provides ...
by:MMS Holdings Inc. based inCanton, MICHIGAN (USA)
Forward-thinking medical and regulatory writers that produce cohesive, scientifically-accurate, and regulatory-robust ...
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:ZebraSci Inc. based inTemecula, CALIFORNIA (USA)
Drug delivery devices come in many forms from the proven PFS to sophisticated auto injectors and needle free systems. ZebraSci actively invests in the testing capabilities and engineering expertise required to evaluate the new drug delivery systems continually coming to market. Needle based injection systems (injector pens, auto injectors, multi-dose systems) are ...
Manufactured by:Creative Bioarray based inShirley, NEW YORK (USA)
Creative Bioarray provides various in vitro ADME/PK services including high-throughput ADME screening, in vitro metabolism, in vitro permeability and transporter assays. ADME is short for "absorption, distribution, metabolism, and excretion". The four properties determine the drug level within a body, the drug exposure to tissues, and the metabolic process of a compound, which can help predict ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Aggregation or fragmentation of protein molecules primarily causes variations in molecular size, impacting their biological activity, stability, and their efficacy and safety as pharmaceuticals. In the development and production of biopharmaceuticals, even slight variations in molecular size can reduce drug efficacy or pose safety risks. Thus, ...