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Drug Developers Services In Usa New Jersey
19 services found
by:Solvias AG based inKaiseraugst, SWITZERLAND
Long-term stability studies according to ICH guidelines. On-going and follow-up stability studies. Comparability studies. Stress tests, forced degradation. Photostability testing according to ICH guidelines. In-use tests, freeze-thaw cycles. Excipient/API compatibility. Interaction studies with primary packaging. Stability protocols, reports and interim reports. Stability indicated method ...
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:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
A 505(b)(2) drug development project represents a streamlined regulatory strategy for many pharmaceutical products today. The provisions of 505(b)(2) were created to avoid unnecessary duplication of studies already performed on a previously approved product. A 505(b)(2) new drug application contains full safety and effectiveness reports on the ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
We offer one of the broadest ranges of biologics and other large molecule analytical services in the industry, all under full CGMP compliance. Our biologics analytical services can be provided as a standalone service or integrated into development and manufacturing. We provide services for drug substance, drug product, and intermediates, both New ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Biological formulation development involves discovering solutions for the most bioactive, native protein delivery. It poses a myriad of challenges due to the fact biologics consist of generally large, complex molecules that complicate drug development. Biologics are at the forefront of many current medical advances. ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
The majority of drugs are administered as solids. This means that apart from the molecular structure of the active ingredient, solid-state properties significantly influence the performance of the final product. New substances with pharmaceutical activity are often weak acids or bases or may have unsuitable solid-state properties. In such cases, it may be preferable to ...
by:Champions Oncology, Inc. based inHackensack, NEW JERSEY (USA)
Champions Oncology is transforming drug discovery and development through our integrated scientific approach. Our expert team works to improve cancer outcomes each day for our research partners and ultimately patients across the ...
Manufactured by:Meda BioTech, Inc. based inWest Berlin, NEW JERSEY (USA)
Meda's Hybrid-Naiioeiigiiieeriiig™ drug delivery platform generates more commercial opportunities than we can pursue independently. Strategic partnering is thereforea critical component of our ability to advance Meda's novel therapeutics programs into clinical developmentand onto the ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
We understand that early assessment of a protein biopharmaceutical’s stability can be invaluable, even during pre-development. For drug substances and drug products all stability aspects can be monitored including long term and accelerated stability studies, in use studies, short term temperature excursion studies, and forced degradation ...
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 ...
Manufactured by:Synbio Technologies LLC based in, NEW JERSEY (USA)
Antibody sequencing and analysis also plays a key role for researchers publishing articles and apply for patents. The data is even more critical for pharmaceutical enterprises to further their research and develop novel drugs. Synbio Technologies can quickly and accurately sequence and analyze antibody sequences with our advanced GenoTM Ab Platform. Using this ...
Manufactured by:SEQENS Group based inÉcully, FRANCE
Seqens provides active pharmaceutical ingredient (API) and drug substance development services to support emerging and large pharmaceutical customers in human and animal health with their pharmaceutical and biotechnology applications for complex, niche and small molecule programs through two main R&D locations in the regions of Boston and ...
by:Freyr Solutions based inPrinceton, NEW JERSEY (USA)
After years of successful clinical research, submission of documents for Health Authority (HA) review requires a specialized skill of clear and precise clinical report writing. Such clear and precise clinical writing aids reviewers to easily comprehend the technicalities of clinical research, as a single error in clinical documentation may prove risky and costly for organizations, causing delays ...
by:Excelra based inIselin, NEW JERSEY (USA)
As the volume of biomedical data increases, so does the complexity of drug discovery and development programs. There’s a wealth of opportunity out there but capturing high-quality data and putting it to immediate productive use is often expensive and inefficient. We know that data alone can’t provide insight. ...
by:Ascendia Pharmaceutical Solutions based inNorth Brunswick, NEW JERSEY (USA)
In the intricate landscape of biopharmaceuticals, development timing is a critical factor that can significantly impact the success or failure of a drug. Saving time can mean the difference between being first to market for a new drug class or a first-to-file ...
Manufactured by:Catalent, Inc based inSomerset, NEW JERSEY (USA)
Drug product development can be a daunting and expensive process. 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 ...
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:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. Successful formulation development can ...
Manufactured by:Ascendia Pharmaceuticals based inNorth Brunswick, NEW JERSEY (USA)
Parenteral formulation development for drugs delivered by injection or infusion is the fastest and the second most common route of drug administration. These formulations must achieve good compatibility of the drug substances with the excipients and the primary container. ...