The GLP Monitoring is intended to ascertain whether test facilities claiming GLP compliance for a study have implemented fully the GLP principles.
What Are The Benefits Of cGMP AuditBesides meeting regulatory and customer requirements, there are numerous other benefits to receiving a cGMP audit.
Some of these benefits include the following:Reduction in failed product testingImprovement of product safetyImprovement of product quality and consistencyEliminating potential risks and possible recallsMarketing advantages over competitors who are not audited by a third-partyImprovement to consumer confidence and an increase in brand loyaltyOxter Research an India Based Pharmaceutical Research Company founded in 2015 with Pharmacovigilance services in India and
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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.
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Oxter Research an India Based Pharmaceutical Research Company founded in 2015 with Pharmacovigilance services in India.
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Our vigilance teams deliver a complete range of Pharmacovigilance services designed to ensure patient safety is covered in every stage of the drug life cycle.
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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.
0
The GLP Monitoring is intended to ascertain whether test facilities claiming GLP compliance for a study have implemented fully the GLP principles.
Our vigilance teams deliver a complete range of Pharmacovigilance services designed to ensure patient safety is covered in every stage of the drug life cycle.
What Are The Benefits Of cGMP AuditBesides meeting regulatory and customer requirements, there are numerous other benefits to receiving a cGMP audit.
Some of these benefits include the following:Reduction in failed product testingImprovement of product safetyImprovement of product quality and consistencyEliminating potential risks and possible recallsMarketing advantages over competitors who are not audited by a third-partyImprovement to consumer confidence and an increase in brand loyaltyOxter Research an India Based Pharmaceutical Research Company founded in 2015 with Pharmacovigilance services in India and
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.
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.
Oxter Research an India Based Pharmaceutical Research Company founded in 2015 with Pharmacovigilance services in India.