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Approved Drug Services In North America
16 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 ...
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: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 ...
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. ...
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: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: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: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: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 ...
by:CureMatch, Inc. based inSan Diego, CALIFORNIA (USA)
The comprehensive analysis considers commonly used treatments, as well as targeted therapy, immunotherapy, hormone therapy, and newly approved oncology drugs. These options are presented either alone (monotherapy) or in combinations of up to 4 ...
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: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. ...
by:MtoZ Biolabs based in, MASSACHUSETTS (USA)
Peptides are compounds formed by multiple amino acids linked by peptide bonds and can be prepared via recombinant DNA expression, biological extraction, or chemical synthesis. Peptides represent a unique class of drugs with certain characteristics of small molecule drugs as well as properties of large proteins and other biologics. Most intrinsic signaling molecules are peptide-based, such as ...
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 ...