TRIUMPHARMA LLC.

TRIUMPHARMA was founded in 2002 , is a full service CRO that supports the pharmaceutical and the biotech industries in introducing new solutions to the pharmaceutical markets, with core strength in : Clinical Trials [Phase I - Phase IV] including Clinical Data Management and BE/BA studies. Over the years we have successfully conducted more than 300+ US-FDA submissions , EU/ANSAM/Bfarm/MHRA submissions (NDAs & ANDAs) and MENA/JFDA submissions, using HVs and patients in various therapeutic areas such as CV diseases, Gastro-intestinal disorders, Respiratory/Pulmonary disorders, Metabolic disorders, Endocrinology, Nephrology/Hepatology, Rheumatoid Arthritis Disorders of immune systems, Neurology/Psychiatry, Gynecology, Acute/Chronic infections and Oncology. TRIUMPHARMA has experience in many of the POC indications, in addition to our experience in early phase studies such as Asthma, NASH, Parkinson, AF, Diabetes, and others. We have also conducted many studies on monoclonal antibodies including HAE and biosimilar /biotech products. TRIUMPHARMA encompass a total bed capacity of 80 beds across our two floors ((over 200 beds with our hospital sites) and 5 LC/MS/MS machines. We have a dedicated facility and team for Phase I-IV clinical trials conducted in compliance with ICH GCP guidelines. And we have our own diagnostic and screening medical lab, Bioanalytical lab with state of the arts LC/MS/MS equipment’s, the trained PIs, Research Nurses, CRCs, CRAs, Project Management, certified and trained Spirometer technicians, dedicated Data Entry team with familiarity with the relevant and most updated clinical software’s used in trials, Qualified site and IMPs Depot .We are also able to offer our clients the benefit of a large collective experience when formulating and implementing regulatory strategies and study designs. We have successfully been inspected by US-FDA , EMA, French Ministry of Health-ANSM, German Ministry of Health- Bfarm, Turkish MOH, GCC, UAE MOH, JFDA,