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Method Validation Suppliers In Usa
33 companies found
based inEast Rutherford, NEW JERSEY (USA)
With 40 years experience and a growing team of over 2,200 experts servicing global clients from our sites in North America and Europe, we are tried and trusted in branded and generic markets for API and dosage form development and manufacturing. We ...
Cambrex has extensive experience in Drug Metabolism and Pharmacokinetic (DMPK), Bioanalytical and Biopharmaceutical Analyses. The Biopharmaceutical Analyses scope supports GMP method development, validation, and ...
based inEureka, CALIFORNIA (USA)
S-Matrix develops advanced and innovative Quality by Design software. S-Matrix has changed our product name from Fusion AE to Fusion QbD® as an acknowledgement of our commitment to developing software that is 100% aligned with Quality by Design ...
based inHamburg, GERMANY
Revvity Gene Delivery (formerly SIRION Biotech) supports your cell and gene therapy development process ̶ offering solutions for early R&D all the way to clinical applications, with easy transfer of processes and assays into GMP production. ...
based inLinthicum, MARYLAND (USA)
Family-owned since its founding in 1967, GERSTEL is committed to developing and producing comprehensive, highly efficient solutions for automated sample preparation and sample introduction for GC-MS and LC-MS. The main focus is on automated sample ...
based inSan Jose, CALIFORNIA (USA)
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous ...
The main purpose of stability program is to evaluate a shelf life for a product to enter a market and before that determine a safe stability profile during clinical trial. There are many guidance which showcase the best practices how to achieve a ...
based inBothell, WASHINGTON (USA)
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from ...
AGC Biologics develops and manufactures diverse cell therapies including CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells. Our cell therapy capabilities cover numerous technologies, ranging from closed to open ...
based inShirley, NEW YORK (USA)
CD Formulation is a leading manufacturer of excipients, serving the pharmaceutical industry to help it improve the performance of its products. We develop, produce and sell pharmaceutical excipients for solid, semi-solid and liquid dosage forms. Our ...
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 ...
based inNewark, CALIFORNIA (USA)
ACD - a Bio-Techne brand, shortens the path to personalized medicine and enables research, drug development and clinical applications by unlocking the power of RNA. ACD is a leader in the emerging field of molecular pathology, developing cell- and ...
based inSeattle, WASHINGTON (USA)
Nexelis is your partner for assay and biomarker development, advanced bioanalytical and laboratory testing, and translational immunology. As the leading specialty laboratory, we have unrivaled expertise in immunology, specifically in the areas of ...
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 ...
based inBurlington, NEW JERSEY (USA)
International Products Corporation manufactures a line of free-rinsing concentrated cleaners and P-80 temporary rubber assembly lubricants at their ISO:9001 Certified facility in Burlington, NJ. They are equipped with state-of-the-art manufacturing, ...
based inMorton Grove, ILLINOIS (USA)
Regis Technologies, Inc. partners with pharmaceutical and biotechnology companies to help expedite their drug candidates to market. Regis has the technical and operational capabilities to fully support our clients' preclinical and clinical API ...
based in, MASSACHUSETTS (USA)
MtoZ Biolabs is an integrate contract research organization (CRO) providing advanced proteomics, metabolomics, bioinformatics, and biopharmaceutical analysis services to researchers in biochemistry, biotechnology, and biopharmaceutical fields. The ...
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 ...
based inParis, FRANCE
Qynapse, through QyScore, brings groundbreaking peace of mind to the global fight against CNS disease. Qyscore is a medical device software FDA-cleared – class II and CE-marked – class IIa (CE BSI). Qyscore is a medical device software FDA-cleared ...
based inAustin, TEXAS (USA)
Everlywell offers health and wellness solutions including laboratory testing for wellness monitoring, informational and educational use. With the exception of certain diagnostic test panels, list available here, the tests we offer access to are not ...
based inSeattle, WASHINGTON (USA)
Headquartered in Seattle, Avaden Biosciences operates the largest human biosample network in the world. Our U.S.-based partnerships with over 200 CLIA/CAP accredited facilities provide immediate access to more than 35,000,000 highly annotated ...
based inGoettingen, GERMANY
We provide the essential products, technologies and expertise to produce biopharmaceuticals reliably and efficiently. In fact, Sartorius has been pioneering and setting the standards for single-use products that are currently used throughout all ...
based inBaltimore, MARYLAND (USA)
Sapio Sciences is a leading provider of Laboratory Management, Electronic Lab Notebook, and Knowledge Management Solutions. Sapio is at the forefront of the Digital Lab with its science-aware platform for managing all your life science data with its ...
based inSaranac Lake, NEW YORK (USA)
Bionique Testing Laboratories LLC has advanced into an international leading provider of mycoplasma testing services for the life science industry. Bionique’s unwavering commitment to quality continues as we celebrate the 30-year milestone ...
based inRaleigh, NORTH CAROLINA (USA)
Ofni Systems, a private computer compliance services and software company, is headquartered in Research Triangle Park, NC. Ofni Systems was founded in 1999, dedicated to helping companies address the requirements of 21 CFR Part 11, Electronic ...
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. ...
based inDurham, NORTH CAROLINA (USA)
Welcome to Patheon. With a commitment to quality, scientific excellence and exceptional customer experiences. Patheon is a leading provider of drug substance and drug product services for the global biopharmaceutical industry. Patheon’s global ...
