- Home
- Services
- north korea
- method validation
Refine by
Method Validation Services Available In North Korea
19 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: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: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: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 ...
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: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: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: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. ...
by:Biovian Oy based inTurku, FINLAND
Adenoviruses are attractive tools for gene therapy, including immuno-oncology, because of their well-defined biology and characteristics including the possibility for large gene inserts. Biovian has proven expertise in adenovirus vector process development, GMP production, and analytics. Since 2004, we have developed processes and have manufactured over 40 clinical adenovirus GMP batches for our ...
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. ...