- Home
- Services
- luxembourg
- drug application
Show results for
Refine by
Drug Application Services Available In Luxembourg
15 services found
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 ...
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: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 ...
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:Pace Analytical based inRoseville, MINNESOTA (USA)
From early strategy discussions and meetings with agencies to submissions and applications support on through commercialization, we help our clients with regulatory, compliance, validations, training, and auditing support. Our understanding of domestic and international biotech and pharmaceutical operations and of the regulatory challenges facing these industries allows our ...
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 ...
Manufactured by:Firalis Group based inHuningue, FRANCE
The successful implementation of a biomarker endpoint is highly dependent on the availability of assays and on reliable measurements of markers in biological samples. While a large number of assays are on the market, scientists often have an urgent need for assays meeting specific ...
by:Pace Analytical based inRoseville, MINNESOTA (USA)
With more than 20 years of experience in pharmaceutical research and manufacturing, we understand the specific challenges aseptic fill-finish and manufacturing presents. Our facility is carefully designed with the flow of personnel and materials in mind, which follows current Good Manufacturing Practices (cGMP) guidelines and minimizes contamination or mix-ups. Flexibility is important during ...
Manufactured by:Creative BioMart based in, NEW YORK (USA)
Creative Biomart provides drug analysis service for pre-clinical drugs and natural products on their physical and chemical properties. Our services include three main assays: pre-clinical pharmaceutical property analysis, pharmacokinetics analysis & bioanalysis, andnatural product ...
Manufactured by:MedGenome Inc. based inCounty of New Castle, DELAWARE (USA)
Profiling the Tumor Microenvironment: Using a genomics based approach to analyze the tumor microenvironment can provide unique insights beyond IHC and FACS methods. OncoPeptTUME deeply interrogates RNA-Seq data sets to produce high resolution mapping of the tumor microenvironment using proprietary cell type specific gene expression signatures. OncoPeptTUME provides a critical assessment of the ...
Manufactured by:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Acute Radiation Syndrome (ARS) involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells, as well as to other systems and organs. Severe damage to bone marrow makes victims vulnerable to life-threatening hemorrhage, infection and anemia. ...
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 ...