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Risk Based GCP & GLP Monitoring & Audit/GLP Compliance

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  GLP Monitoring is an essential activity to ensure the quality of the clinical trials, and also we understand issues at both CRO and sponsor levels. Our well qualified and trained monitors are responsible for ensuring that the study conducted in accordance with the protocol, GCP, GLP, and applicable ethical and regulatory requirements. Our team can fully integrate into the study teams of sponsors or CROs while the conduct of the study, nonetheless monitors are independent of the personnel performing the study. We provide a written report after each site visit. If any issues observed during monitoring, our expert communicates to the CRO and Sponsor as quickly as possible, to mitigate the observed problems. We also suggest and enable prompt corrective actions to mitigate the risk associated with the issues. Such communications and corrective actions shall be documented and provided to the Sponsor. Our well defined SOPs with separate checklists for the initiation visit, routine moni
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Pharmacovigilance services | Oxter Research

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  Pharmacovigilance services are an area that obviously no pharmaceutical company can afford to make a single mistake with. It can be a time-draining task to decipher all the information from prospective pharmacovigilance companies, costing you valuable working hours. This article therefore gives a simple perspective on the overall operational requirements providers should offer, which could more efficiently streamline the entire process at both pre and post marketing authority levels. By spending ten minutes reading this, you can come away with a basic checklist from which to start researching potential pharmacovigilance solutions providers with more informed insight and direction. Pharmacovigilance solutions providers should be able to offer you comprehensive services during the pre marketing and post marketing phases for each product. This simple 'rule' can avoid having to waste time and potentially substantial amounts of the budget handing over to new pharmacovigilance
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What is cGMP & Why Is It So Important?

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  Good Manufacturing Practices (cGMP) are minimum requirements to ensure that products are created in a manner that ensures they are of consistent quality and safe for their intended use. If a product is found to be produced in a facility that does not meet GMPs, they can be considered adulterated and unsafe. In the U.S., the U.S. Food & Drug Administration (FDA) regulates the manufacture and sale of food and beverages, dietary supplements, pharmaceutical products, and cosmetics by requiring adherence to GMPs. The “c” in cGMP stands for current, meaning that how companies conform to GMPs must continually evolve with the development of new scientific research and industry best practices. Why Is It So Important? cGMPs are important to ensure manufacturers are producing safe products. A site that is not following the minimum requirements for cGMPs is putting the basic well-being of consumers around the world at risk. What Are The Benefits Of cGMP Audit Besides meeting regula
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