WELCOME TO MEDEXCEL MIDDLE EAST
WELCOME TO MEDEXCEL MIDDLE EAST
Patient safety has always been a critical concern for sponsors. Today, the remit of Safety has expanded, making it a critical component in core processes for Life Sciences companies. Hence, drug safety departments are increasingly focusing on core activities, to contribute their insights throughout the product lifecycle to ensure better risk management and effective market interventions.
In addition, sponsors are under pressure to achieve greater efficiency in the face of growing regulatory and compliance expectations. This had made it crucial for Life Sciences organizations to leverage technology to automate processes, use data to drive insights and hence, improve efficiencies while supporting the safety profile of their drugs.
Our end-to-end services span clinical R&D, review & registration and post-marketing phases. Our established PV framework supports clinical and commercial products. Our Consulting Team has defined and implemented PV processes, governance practices and even organizations in many Life Sciences companies.
Many of the top biopharma companies are members of our Safety Networks. They benefit from round-the-year insights on operational performance, compliance and the latest trends highlighted during our frequent interactions with our experts.
This wealth of experience and PV knowledge combined with our Technology capabilities is utilized across all our PV services and solutions.
We provide full-fledged end to end ICSR Management solutions from data collection, data entry, quality and medical review and proactive case follow-up for regulatory submission of ICSRs. We at Medexcel ME provide full support for each step of the ICSR handling process and manage your safety data and meet all your ICSR requirements.
Our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We can support you with advice in aggregate safety data analyses and in overall benefit-risk assessments
Global and Local Literature Monitoring: Our services include periodic and bespoke literature searches across various local journals in respective countries in different languages.
Our literature specialist team has over 15 years’ experience in global pharma with a focus on literature monitoring
Our team of experts is able to create bespoke training courses that can be delivered remotely or onsite .
We are equipped with fully supported safety database solution for a compliant and effective pharmacovigilance system
Our experienced pharmacovigilance team has the expertise to manage the efficient and effective detection and management of Signals for all your investigational and authorized medicinal products, optimizing your patients’ safety, and assuring the compliance of your PV system.
We have a comprehensive understanding of the PV requirements in markets around the world, and based on that wide experience, we know how to meet all your local PV requirements.
This service includes, but is not limited to:
Our expert team continually screen for these changes around the world to provide a fast and efficient interpretation and assessment of them for their impact on procedures and strategy as a part of minimizing your risk.
Copyright © 2023 MedExcel Middle East - All Rights Reserved.