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Method Validation Services
38 services found
Manufactured by:Recipharm AB based inStockholm, SWEDEN
We provide analytical validation in compliance with the European Pharmacopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) ...
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:BIOVECTRA based inCharlottetown, PRINCE EDWARD ISLAND (CANADA)
BIOVECTRA’s analytical services group supports GMP and CMC requirements from early development to validation of commercial processes and continuous process verification, all along the life cycle of your programs. Our capabilities include regulatory-driven, phase-appropriate testing for both small molecules APIs and biologic drug substances. They cover the full scope of ...
Manufactured by:BCN Peptides S.A. based inSant Quintí de Mediona, SPAIN
Throughout the development and industrial lifecycle of all our APIs, we provide analytical support to contracted customers as required for cGMP compliance. We have extensive analytical expertise and offer all analytical services to ensure successful product development. Our vast platform of state-of-the-art analytical techniques is designed to meet all regulatory requirements for our products ...
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:Recipharm AB based inStockholm, SWEDEN
The flexibility, capacity and expertise to take care of your analytical requirements. At Recipharm,?our analytical experts are here to help you rapidly develop your molecule to successfully bring it to the clinical stage and ...
Manufactured by:Applied Pharma Research s.a. based inBalerna, SWITZERLAND
Pre-formulation development: physical and chemical characteristics of the proposed drug are analyzed to allow selection of optimal excipients and dosage forms. Formulation design: based on the product's physicochemical/release characteristics and other important aspects, a range of theoretical formulations is proposed to determine how they affect the final product's characteristics such as in ...
by:Gesellschaft für Bioanalytik Hamburg mbH(GBA) based inHamburg, GERMANY
In January 2012, LAT GmbH Dr. Tittel Institute for Pharmaceutical Analysis joined the GBA Laboratory Group along with its site in Gräfelfing, Bavaria. LAT GmbH offers comprehensive capabilities in the field of pharmaceutical analysis and is specialized in the following ...
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 ...
by:Mithas Labs Clinical Trials Research Foundation Pvt., Ltd. based inChennai, INDIA
The content of the program can be defined in a number of ways: the purposes of research, research design concepts, data collection methods, and statistical or analytical methods. The program provides concepts and methods that relate to the purposes of clinical research, clinical epidemiology, clinical trials, program evaluation, and technology ...
Manufactured by:CD Formulation based in, 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 ...
Distributed by:KRSS Europe B.V. based inVeenendaal, NETHERLANDS
KRSS has set up a team of Clinical Application scientists with over 60 years’ experience working in clinical laboratories. This means we can now offer clinical application support at affordable prices as well as developing new automated methods in many clinical application areas which can then be offered to our CSP customers as part of their ...
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. ...
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 ...
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: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. ...
Manufactured by:Heppe Medical Chitosan GmbH based inHalle (Saale), GERMANY
You need a chitosan or chitosan derivative for your medicinal product or drug or You are doing industrial research and development? Our products are particularly suitable for your ...