WELCOME TO MEDEXCEL MIDDLE EAST
WELCOME TO MEDEXCEL MIDDLE EAST
MedExcel have successfully supported inspections requested from various organization and our team guarantee inspection readiness. We strive to provide a clear path maintaining compliance in the face of increasing regulatory scrutiny.
Our approach is based on data integrity, scientific evaluation of risks and effective communication, we prepare our clients for routine Good Pharmacovigilance Practices (GVP) inspections, by regulatory authorities and third-party vendors/partners.
Our QA experts steer organizations through follow-up inspections for identified non-compliance issues by establishing Corrective and Preventive Action (CAPAs) plans and periodic progress reports, as required. Our experienced PV experts and trainers help clients to:
Adherence to policies, plans, procedures, laws, regulations is critical to ensure compliance with the evolving Regulatory requirements. MedExcel provides support in audit-related activities including audit plan, audit conduct, audit findings.
We are experts in GVP, GDP, GCP, MI, Regulatory and PV/QMS IT systems. Our team is headed by a trained GVP, GCP, MI auditor with over 16yrs experience. We have the global reach to manage the breadth of your Audit Universe across all levels of services.
We offer many QA management services, and our experienced staff are enthusiastic to ensure compliance. Our QA Management service has been highly valuable to our clients. This service allows your organization to access our experienced consultants to help support and build QA within your organization.
Planning, Preparation and Support.
The more preparation and planning you can do, the less stressful the inspection experience. Our knowledgeable and attentive staff are here to help you.
A high-level review, to ensure all required procedures are in place to ensure your ongoing compliance. A report can then be provided on any potential gaps and we can offer additional support in addressing them.
MedExcel (SDEA) Safety Data Exchange Agreements / PV Agreements (PVA) can house all the partner agreements, pharmacovigilance agreements and bind all legal contracts, ensuring that all safety information pertaining to a licensed product is swiftly and reliably returned to the marketing authorization holder so that they may fulfil their legal obligations to compile safety information and to timely submit safety reports.
Compliance management is key to all our services to ensure we are offering the best practices. Compliance management is a key during inspections and we can support you in setting up your compliance framework to support with your needs
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