Drug Approval Services
21 services found
by:Nexreg Compliance Inc. based inLondon, ONTARIO (CANADA)
Nexreg can work with your company to develop drug product labels which meet Canadian requirements. As well, Nexreg's team of experts will complete the DIN Submission Certification form required by the Therapeutic Products Directorate (TPD) of Health Canada. The Drug Identification Number (DIN) is the number located on the label of prescription and ...
Manufactured by:Regis Technologies Inc. based inMorton Grove, ILLINOIS (USA)
Regulatory agencies have acknowledged impurities, especially potential genotoxic impurities (PGIs), as a high priority in the drug development approval process. Since impurities found in pharmaceutical drug substances can potentially exhibit pharmacological activity, there are reporting, identification, and qualification thresholds dictated by ...
by:Natera, Inc. based inAustin, TEXAS (USA)
Why partner with Signatera for your clinical trial? Clinically validated across multiple solid tumors, Signatera has shown to predict relapse in >98% of patients without further treatment. Experienced team with Global reach: CE Mark, three FDA Breakthrough Device Designations, 8 Non-Significant Risk (NSR) determinations. >60 Natera IP assets covering ctDNA MRD and ...
Manufactured by:Cellworks Research India Private Limited based inBangalore, INDIA
Accelerate drug development timelines, reduce risks and lower costs. Our biosimulation platform predicts human clinical response to investigational drug candidates YEARS earlier than traditional development ...
by:Eurofins bioskin ( formely Bioskin GmbH) based inHamburg, GERMANY
The path to approval for generic topical products can be challenging. bioskin can help you to optimally plan and implement a development strategy: Vasoconstrictor assays according to FDA guidance: Bioequivalence of topical corticosteroids in Europe and the USA is assessed using the vasoconstrictor or human skin blanching assay as outlined in the FDA guidance. bioskin offers a competitive package ...
Manufactured by:Emmaus Medical, Inc based inTorrance, CALIFORNIA (USA)
Under the terms of the agreement, Emmaus Life Sciences and Cellseed will conduct clinical trials to seek Food and Drug Administration approval for use by patients in the United States. ...
by:Molecular Health GmbH based inHeidelberg, GERMANY
Act beyond human and experimental limitations. Knowledge to advance game-changing therapies from idea to market. The world's biomedical knowledge at your fingertips. Reliable predictions to anticipate risks. Interlinked data to find new targets and design novel drugs. Real-world evidence to evaluate success. These capabilities eliminate the uncertainties that limit drug development but are ...
by:International Drug Development Institute (IDDI) based inLouvain-la-Neuve, BELGIUM
Aiming at optimizing your clinical development strategy, our expert consultants develop the innovative strategies and capabilities needed to launch products with the greatest potential for commercial success and improved patient outcomes. ...
Manufactured by:NeuroOne Medical Technologies Corporation based inEden Prairie, MINNESOTA (USA)
Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, ...
Manufactured by:BOC Sciences based inShirley, NEW YORK (USA)
Composed of an assortment of twenty-one libraries including FDA-approved drug library, natural product library, and anti-cancer compound library, among others, the bioactive screening libraries at BOC Sciences are ready-to-use chemical libraries for drug discovery, lab drug screening, drug target identification, ...
by:elminda Ltd. based inHerzliya, ISRAEL
CNS drugs exhibit the lowest approval success rates due to multiple challenges such as lack of efficacy in early and advanced stages of development, Poor target selection / engagement, poor translation from pre-clinical models and disease heterogeneity. BNA may contribute in CNS research and drug development by adding new objective endpoints, ...
by:Asbestos.com, The Asbestos & Mesothelioma Center based inOrlando, FLORIDA (USA)
Photodynamic therapy, also called PDT, is a cancer treatment that uses light energy to kill cancer cells. First, the doctor administers a photosensitizer, a type of drug that makes cells sensitive to certain wavelengths of light. Then the cancer cells are exposed to light, causing a reaction that kills cancer cells nearby. In clinical trials, researchers found that this treatment can improve life ...
Manufactured by:Alfa Chemistry based inNY, NEW YORK (USA)
Ifosfamide has been effectively employed in the treatment of multiple cancers, including testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, non-Hodgkin lymphoma, Hodgkin lymphoma, epithelial ovarian cancer, cervical carcinoma and germ cell carcinoma of the ovary[1]. Among all these cancers, the Food and Drug Administration (FDA) has ...
by:MMS Holdings Inc. based inCanton, MICHIGAN (USA)
Forward-thinking medical and regulatory writers that produce cohesive, scientifically-accurate, and regulatory-robust ...
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:SAGA Diagnostics AB based inLund, SWEDEN
Today, we know much about the many mutations which can contribute to cancer, some mutations which can be inherited, as well as the many gene mutations which arise randomly and due to environmental exposures. Increasingly, these mutations can be targeted by approved drugs as well as dozens of therapeutics currently in development around 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:Pluristem Therapeutics Inc. based inHaifa, ISRAEL
Bone marrow deficiency refers to a condition in which the hematopoietic stem cells in the bone marrow fail to produce enough, or produce abnormal, red blood cells, white blood cells and platelets. Hematopoietic cell transplantation (HCT), the transplantation of multipotent hematopoietic cells, is a standard treatment in various malignant and non-malignant conditions. Transplant patients are ...
Manufactured by:Soteria Medical BV based inArnhem, NETHERLANDS
Prostate cancer incidence rates rose dramatically in the late 1980s, when screening with the prostate-specific antigen (PSA) test, which received initial U.S. Food and Drug Administration approval in 1986, came into wide use. It is estimated that approximately $9.9 billion is spent each year in the United States on prostate cancer treatment. (National Cancer ...
Manufactured by:Micropore Technologies Ltd. based inRedcar,, UNITED KINGDOM
Commercialisation of sustained release formulations began in the 1970s with PLA & PGA used for surgical implants and sutures. 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 ...