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Drug Application Services
34 services found
Manufactured by:Creative Biolabs based inShirley, NEW YORK (USA)
Custom tailored thermal shift assay services with several applications of drug discovery. ...
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 ...
by:Intertox, Inc. based inSeattle, WASHINGTON (USA)
FDA Liaison – Provide guidance and/or serve as a direct liaison with the FDA for the coordination of Prescription Drug User Fee Act meetings. Non-clinical Regulatory Support – Manage Investigational New Drug Applications’ toxicity studies, associated non-clinical safety studies, and biological activity programs to support ...
by:Solvias AG based inKaiseraugst, SWITZERLAND
Solvias provides comprehensive cGMP services at every stage of drug development. We can fully characterize any protein biopharmaceuticals for the Chemistry and Manufacturing Controls (CMC) section of Investigational New Drug applications (INDs), New Drug Applications (NDAs) and Biologic License ...
Manufactured by:OnLume Inc. based inMadison, WISCONSIN (USA)
OnLume Surgical’s novel approach to fluorescence-guided surgery provides superior imaging with high sensitivity allowing low fluorescent drug concentrations – even under ambient OR light conditions. And, our imaging device is adaptable and applicable to a broad spectrum of targeted fluorescent drugs for applications ...
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 ...
Manufactured by:ClearLight Biotechnologies, Inc. based inMountain View, CALIFORNIA (USA)
Long before your team will experience commercial success with your brand name drug, preclinical drug development activities take center stage. By the time you submit your investigational new drug (IND) application you’ll want to retire as many risks as possible and have confidence that your experimental ...
Manufactured by:Kanomax USA, Inc. based inAndover, NEW JERSEY (USA)
The expanding bio-technology field is creating a greater demand for mass spectrometry, as this technology is vital to human safety and quality of living. Two key areas are improving quality in environmental management and air quality management. Other applications include: drug detection, chemical analysis of food and the analysis of environmental contaminates. ...
by:Ergomed based inSurrey, UNITED KINGDOM
Global regulatory framework assessment tool. This heat-map assesses the suitability of the country's regulatory framework based on your protocol. Simply enter details of your trial design to see which countries will facilitate fast approval and which ones will be more challenging. The fastest countries will be colored the darkest, more challenging the lightest and white where it's not possible. ...
by:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
by:First Advantage based inSt Petersburg, FLORIDA (USA)
First Advantage is a certified FBI Channeler and approved for submitting fingerprints to the Florida Department of Law Enforcement (FDLE), allowing us to process tens of thousands of fingerprints annually on behalf of companies nationwide. First Advantage systems also securely connect to the Financial Industry Regulatory Authority (formerly NASD). Additionally, First Advantage provides ...
Manufactured by:Micropore Technologies Ltd. based inRedcar,, UNITED KINGDOM
PLGA (Poly (lactic acid-co-glycolic acid)) quickly emerged as the most important biocompatible, non-toxic polymer with numerous applications in drug delivery, tissue engineering, medical and surgical ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Antibody drug developability analysis (drugability analysis) is a key strategy used to evaluate the development prospect of candidate antibody drug. This analysis is based on a comprehensive evaluation of multiple aspects of the candidate antibody, including biological activity, pharmacology, pharmacokinetics, safety, and preparation feasibility. Through ...
Manufactured by:AGC Biologics based inBothell, WASHINGTON (USA)
AGC Biologics has a strong regulatory track record. We have been successfully inspected by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Danish Medicines Agency (DMA), the Paul Ehrlich Institute (PEI), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA). The many audits and inspections conducted at AGC Biologics have helped us continuously ...
by:Latham BioPharm Group based inElkridge, MARYLAND (USA)
Strategic regulatory planning and implementation is a critical component of any product development program. Understanding the regulatory pathway up front not only allows for clarity in the development process but can also save valuable time and ...
Manufactured by:Piramal Pharma Solutions (PPS) based inMumbai, INDIA
Piramal’s regulatory team, provides expert clinical & regulatory support through all phases of drug development. This includes regulatory support on New Chemical Entity’s (NCE), Clinical Trials, Marketing products, Generics, OTC ...
Manufactured by:Zeus Industrial Products, Inc. based inOrangeburg, SOUTH CAROLINA (USA)
As we enter our sixth decade, Zeus continues to explore new methods to make our products better and find creative ways to enhance the lives of those around us. After expanding our capabilities with the introduction of bioabsorbable products including those based on polylactide (polylactic acid, PLA), we have developed a technology for recycling PLA. The new, low-temperature method of recycling ...
by:OHS Inc. based inCosta Mesa, CALIFORNIA (USA)
Employee drug testing works! Since 1988, “The Drug Testing Index”™ report by Quest Diagnostics Laboratories has been updated and released annually. Their most recent report is based on more than 10 million drug tests of USDOT-regulated, "safety-sensitive", and "general workforce" employees performed during 2021. The success of employee drug testing has long-ago been confirmed! ...
Manufactured by:AnaBios Corporation based inSan Diego, CALIFORNIA (USA)
EX VIVO Human Platforms for Cardiovascular Drug Discovery. Broadly defined, cardiovascular disease is the leading cause of death for men and women across most racial and ethnic groups in the United States with one person dying approximately every 34 seconds1. To drive successful clinical translation of new cardiovascular medicine, AnaBios develops relevant human ex vivo platforms for many ...
by:Cytotheryx, Inc. based inRochester, MINNESOTA (USA)
At Cytotheryx, we understand that life-saving discovery in liver disease research and medicine requires a multi-faceted approach. The key to enabling this innovation is a reliable foundation. We understand this need and the opportunity to support numerous areas working to advance human health—this is our sole ...