Regulatory Quality and PV

The company has established quality systems that are the backbone of all its activities, ensuring processes, procedures and documentation are in line with the latest Guidelines of Goods Distribution Practices and Goods Pharmacovigilance Practices (such as temperature mapping and monitoring, cleaning, maintenance, transportation, pest control, Stock rotation and stock management systems, stock disposal, documentation, cold-chain maintenance, and record keeping etc.) It is also responsible for ensuring quality systems are maintained by regular yearly training of employees, training evaluation, internal audits, review of corrective actions and quality assurance procedures that ensure quality of products and procedures is monitored, maintained and where necessary, improved.

The regulatory office also provides support for Pharmacovigilance activities such as reporting of Adverse Drug Reactions, Product Quality Complaints, Service complaints, batch recalls, literature review, monitoring of local legislation and guidelines, signal detection, Implementation of Risk Management Plans, distribution of Dear Healthcare Professional Communications etc.

It also supports Marketing Authorization Holders’ (MAH) regulatory offices for the provision of product exposure data and submissions of various documents such as application forms, Periodic Safety Update Reports etc. and provides as an efficient link between the local national health authority and the MAH to ensure any queries on both sides are addressed in a timely and professional manner. The office also offers translation service agreements for the outsourcing of translations of product documents as well as translation reviews before submission to the authority and post-reviewing support during the Quality Review of Documents.

To contact the regulatory office about services offered by the regulatory office, or make any regulatory queries related to the products distributed by EKLIL Healthcare Ltd. please email regulatory@eklil.com

For any product or service complaints, reporting of Adverse drug reactions or communications related to the safety profile of any product distributed by EKLIL Healthcare Ltd. please email pv@eklil.com

In case of an emergency, you may call the service number on +218213636130 or +218213636131, Fax on +218213636132 .