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Method Validation Services In Usa
22 services found
Manufactured by:RTI Surgical based inAlachua, FLORIDA (USA)
We provide an additional measure of safety by adhering to strict donor screening criteria and tissue preparation methods validated to address potential disease ...
by:Materials Analytical Services, LLC (MAS) based inSuwanee, GEORGIA (US) (USA)
MAS is an ISO 17025 DEA registered cGMP laboratory. We offer accredited analytical testing services and client specified research and method development to the pharmaceutical industry. MAS tests raw materials and formulation excipients and can also implement specific compendial methods as well as perform Certificate of Analysis (COA) verification. Utilizing ...
Manufactured by:Resolution Medical based inFridley, MINNESOTA (USA)
Bench model development & testing. Pre-clinical study support. Engineering Feasibility Studies. Design and Development. Test Method Development & Validation. Design Verification Testing. Design Validation Testing. Process Development and Validation. Clinical and Regulatory Support?. Transfer to Manufacturing. Supplier ...
Manufactured by:Minaris Regenerative Medicine, LLC based inAllendale, NEW JERSEY (USA)
To ensure we provide the best possible service to you, Minaris Regenerative Medicine and our cell & gene therapy specialists offer guidance at every stage of your process. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
The analytical aspects of pharmaceutical development are demanding, as in contrast to pure drug substances, matrix effects need to be taken into account. As one of the most skilled and experienced companies in the field of pharmaceutical development analytics, we can meet your ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
CD Formulation's self-emulsifying drug delivery system service can evaluate the bioavailability of drugs and suggest suitable product solutions. Our professional team has the ability to establish and validate analytical methods, determine oil/water partition coefficients, investigate the equilibrium solubility of drugs in water, oil, surfactants, and provide ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Process, Design, and Equipment Validation are the formal processes for establishing objective evidence that systems consistently produce results or products meeting predetermined specifications, as required by the Federal FD&C Act and cGMP. Validation is an excellent tool to understand and maximize value from your business processes. Validation is also a compliance issue; the FDA requires ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
At Cambrex, we’re equipped to analyze raw materials to support pharmaceutical and medical device product development and manufacturing. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We provide rapid and comprehensive support for your early-phase drug development process, enabling you to establish 'critical mass' – in terms of personnel and know-how – in the chemical and analytical development of complex small-molecule ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Ascendia develops and evaluates a variety of formulations for preclinical non-GLP and GLP studies. We understand the needs of companies with an exciting compound in the discovery pipeline, but with limited amounts of drug substance. We have developed methods for carrying out formulation screening studies with as little as several mg of drug substance. These methodologies can be used to formulate ...
Manufactured by:Bio-Rad Laboratories, Inc. (Antibodies) based inHercules, CALIFORNIA (USA)
When you are trying to characterize a novel protein, or you have developed a unique biological product, often the specialized antibodies you need just don’t exist. What if there was a technology that could overcome this limitation, allowing you to carry out research that was previously impossible? Find out how Bio-Rad's custom antibody services can provide the solution. ...
by:Lighthouse Lab Services based inCharlotte, NORTH CAROLINA (USA)
Independent Reference + Physician Office Labs. Looking into starting a laboratory testing business but not sure where to begin? Lighthouse Lab Services has the expertise to get your lab running in as little as 90 days. Whether you are building a lab from the ground up, adding new lines of testing, or simply adding testing capacity – we’re here to ...
by:ALS Environmental based inHouston, TEXAS (USA)
At ALS our Pharmaceutical Division is a provider of testing services to the Pharmaceutical and Healthcare industries in Australia, Europe and Asia. Committed to exceeding customer expectations we are able to provide high quality solutions across a range products, including human and veterinary products, intermediates and raw materials. Testing is conducted according to international standards ...
Manufactured by:Terumo Blood and Cell Technologies, Inc. based inLakewood, COLORADO (USA)
When you are ready to develop and manufacture high-quality solutions, only the winning combination of the right team and the right facility will do. Our United Kingdom manufacturing facility has over 30 years of experience in partnering with global pharmaceutical, medical device and veterinary pharmaceutical companies in the development and manufacturing of ready-to-infuse solutions that span a ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
From Fit-for-Purpose Development to Qualified and Validated Clinical Assays. Nexelis, a Q² Solutions Company, is a leading partner in assay development and technology transfer, with scientific discipline, critical thinking, and agility. Fit-for-purpose assay development on a wide variety of platforms support your small molecule, large molecule, or vaccine program through all phases of ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Biotech companies face many hurdles along the way, including the development and optimization of a scalable, commercially viable formulation while ensuring safety and efficacy of the final drug product. In order to receive regulatory approval, the manufacturing process and validation methods used to evaluate the drug product performance must be accurate and ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
Designed to be an extension of your laboratory, Nexelis, a Q² Solutions Company, supports bioanalysis in all phases with agile assay development to validation mindset. Whether we design a custom bioanalytical assay or support a client’s technology transfer, our method development process results in an optimized assay compliant with global standards. ...
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 becoming more common as they ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses. The Biopharmaceutical Analyses scope supports GMP method development, validation, and routine analysis including but not limited to host cell proteins, host cell DNAs, endotoxins, enzyme kinetics, and even bacteriophage titering assays. ...
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 ...