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Method Validation Services
160 services found
by:Broughton Laboratories based inNorth Yorkshire, UNITED KINGDOM
We have extensive experience in validating analytical test methods for various applications and across a variety of product types in compliance with international regulations. We can assist throughout the entire method validation activity to meet your requirements. This includes project planning, protocol writing, execution, ...
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) ...
by:Ofni Systems Inc. based inRaleigh, NORTH CAROLINA (USA)
Method validation is the documented process of ensuring a test method or assay is fit for its intended purpose. Regulatory guidelines dictate that analytical test methods used during drug discovery, development, and production will be validated and that validation activities will be summarized in ...
Manufactured by:Biodextris based inLaval, QUEBEC (CANADA)
Validation of a method is a critical step of development work. We, at Biodextris, validate your assays to demonstrate that the appropriate performance criteria are met, and the analytical target profile is achieved. Our quality management system ensures validation policies are aligned with the ICH method ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Method Development and Method Validation for Particle Size: The size, distribution and shape of the particle size will affect the quality of drugs, such as dissolution, bioavailability, content uniformity and stability, and ultimately affect the safety, effectiveness and quality control of drugs. ...
Manufactured by:CD Formulation based inShirley, NEW YORK (USA)
Method Development & Method Validation for Solubility and Dissolution Curves: Accurate determination of the aqueous solubility of drugs is very important for understanding quality control and drug delivery issues of pharmaceutical formulations, and is influenced by the physicochemical properties of the drug, the nature of the medium, and the ...
by:ARL-EuTech Scientific based inMount Olive, NEW JERSEY (USA)
Eutech Scientific Services has over two decades of experience in method development and validation. Our expert technical staff enables us to develop and validate specialized methods of analysis for a number of products. We adhere to GLP guidelines of FDA. Our state of the art laboratory is equipped to meet all your analytical ...
Manufactured by:Cambrex Corporation based inEast Rutherford, NEW JERSEY (USA)
The analytical testing methods used to monitor potency and purity for raw materials, drug substances and drug products are your primary view into the quality of your materials. Cambrex focuses on efficiently developing robust and high- quality analytical methods that deliver reliable results. We have a vast range of capabilities in instrumentation and detectors ...
by:GEOAnalytical, Inc based inTwinsburg, OHIO (USA)
GEOAnalytical can provide method validation and development based upon your specific project needs. We can design a protocol to satisfy your intended purpose or requirements, or implement protocols for validation supplied by your staff. We can refine or modify existing methods to better meet your analytical requirements and ...
by:Activation Laboratories Ltd. based inAncaster, ONTARIO (CANADA)
Validation of an analytical procedure is an essential process in the GMP analysis of a pharmaceutical product. This can include Limit tests for the control of impurities and quantitative tests of the active in drug products. Validation parameters as set out by the International Committee on Harmonisation (ICH) are followed.Assay, Impurity and Stability ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
Method Development : We have considerable experience in developing analytical methods for the complete range of our analytical portfolio, and for the entire lifecycle of a drug. Typical applications ...
by:Selvita S.A. based inKrakow, POLAND
Development, optimization and qualification phases are crucial during the drug life cycle. At Selvita we work in efficient and flexible manner, using the best industry practices, in order to support our clients at this important process stage. Our team consists of industry experts with a thorough understanding of the process and long-standing professional expertise in the field, complemented by ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We understand that you need to progress rapidly and cost effectively at the early stage of drug development. Here, our extensive experience saves you time and we can normally apply generic methods to your protein. You can trust us to select promising analytical methods – and carry out development, validation and transfers – within the ...
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Manufactured by:Fluxana GmbH Co. KG based inBedburg-Hau, GERMANY
FLUXANA is an international provider of proficiency testing. We regularly offer proficiency testing for X-ray fluorescence analysis. By participating in proficiency testing, it is possible for our customers to compare their analytical methods and test procedures with other international laboratories. To do this, we regularly have various proficiency tests for typical X-ray fluorescence analyses ...
by:QuoData GmbH based inDresden, GERMANY
In addition to our software for the planning and evaluation of interlaboratory studies, you can utilize our expertise as a service. Our all-inclusive service covers everything from logistics and organization of to execution and ...
by:QuoData GmbH based inDresden, GERMANY
QuoData realizes the validation of your measurement method according to the requirements of ISO 17025. We realize validation studies also for methods where standardized validation approaches cannot be applied. This holds not only for quantitative but also for semi-quantitative or qualitative test ...
by:Enalytic Labs based inEast Syracuse, NEW YORK (USA)
Enalytic has experience in developing methods where a method does not exist or a method has not been validated. Method validation is the process used to confirm that the analytical procedure utilized for a specific test is suitable for its intended use. ...
Manufactured by:Mettler - Toledo Int. Inc based inGreifensee, SWITZERLAND
Validation covers many areas including: method validation, advice and support can be provided in the development of SOPs. - Computer System Validation (CSV) - postal and vendor audits can be conducted to review the product life cycle and quality ...
by:Niracle, LLC. based inNewtown, PENNSYLVANIA (USA)
NiRACLE assists clients in developing NIR-based methods for both GMP and non-GMP applications. Non-GMP NIR methods take advantage of NiRACLE’s proprietary modeling method and are intended for supporting early stage formulation development and late stage commercial production scale up. GMP NIR methods are for tablet content ...
Manufactured by:BenchChem, a brand of Innovation Sciences Inc. based inPasadena, CALIFORNIA (USA)
To help ensure product quality and consistency in both academic and industrial settings, we offer a comprehensive range of tailored analytical methods and perform method validation for specific testing ...