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Method Validation Services Available In Palau
26 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 ...
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: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: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 ...
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 ...
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: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: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:Eurofins Scientific based inKraainem, BELGIUM
Complete preclinical service: Early and full drug development is regulatory-driven and complex. The priority in this selection process is to achieve the safety and efficacy of a new molecular entity. The preclinical activity includes mainly safety and pharmacological testing accompanied by metabolism, bioanalysis, biomarker development and pharmaceutical analysis. Eurofins offers the whole panel ...
by:Emmace Consulting AB based inLund, SWEDEN
ISO 18562-4 addresses the critical need for quantifying and assessing the risks associated with condensate produced during patient use, which can potentially enter the lungs or the throat region depending on the device. Accurate measurement of the condensate volume is essential for ensuring patient safety, meeting regulatory requirements and making it possible to estimate the exposure to ...
Manufactured by:Proteomics International based inNedlands, Perth, AUSTRALIA
Comprehensive suite of new pre-clinical and clinical testing capabilities: pharmacokinetic (PK), pharmacodynamic (PD), and companion diagnostic (CDx) services. Proteomics International applies its proven expertise and experience in targeted mass spectrometry to the field of PK testing. Mass spectrometry is ideal for the accurate and precise quantitation of target drugs and their break-down ...
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 ...