A structured quality framework supporting pharmaceutical integrity, regulatory compliance, risk management, product safety, and controlled distribution across Yemen.
At EndoCare+, quality is integrated into the way pharmaceutical products are received, stored, handled, distributed, and monitored. Our documented quality framework supports product integrity, patient safety, regulatory compliance, and accountability across relevant pharmaceutical operations.
Documented policies, SOPs, controlled procedures, forms, and records support consistent and accountable operations.
Our activities are conducted with consideration of applicable pharmaceutical requirements and the expectations of competent authorities in Yemen.
Quality controls extend across receipt, storage, temperature-sensitive handling, distribution, traceability, complaints, and safety-related processes.
Define quality principles, responsibilities, and organizational commitments.
Establish controlled procedures for relevant operational and quality activities.
Provide documented evidence that defined processes have been performed.
Support identification, assessment, mitigation, escalation, and follow-up of relevant risks.
Relevant quality documentation may be made available through appropriate formal channels and subject to applicable confidentiality and due-diligence requirements.
EndoCare+ applies a risk-based approach to relevant quality and operational activities. Potential risks are identified, assessed, controlled, documented, and escalated according to their nature and potential impact on product quality, patient safety, regulatory compliance, and business continuity.
Identify potential quality or operational risks.
Evaluate likelihood, impact, and relevant risk factors.
Define appropriate preventive or mitigating controls.
Review controls, events, deviations, and emerging risks.
Escalate significant issues and implement corrective or preventive actions where required.
Risk-based thinking supports decision-making across quality, distribution, product handling, safety, and operational continuity.
Maintaining processes aligned with applicable pharmaceutical regulatory requirements.
Protecting product quality throughout relevant handling, storage, and distribution activities.
Supporting appropriate quality and pharmacovigilance processes for safety-related information.
Using quality events, complaints, deviations, and relevant findings to support corrective and preventive action.
For temperature-sensitive pharmaceutical products, appropriate storage, handling, monitoring, and documentation controls are maintained to support product integrity throughout the applicable distribution process.
Explore Distribution & Cold ChainAppropriate temperature-controlled storage for applicable products.
Temperature conditions are monitored and documented according to applicable procedures.
Temperature excursions are assessed and managed through documented processes.
EndoCare+ maintains processes supporting the identification and traceability of pharmaceutical products by batch or lot number. Where a quality or safety concern is identified, appropriate assessment, containment, escalation, and recall-related actions are undertaken in accordance with applicable procedures and regulatory requirements.
Batch / Lot identification and traceability across the supply chain.
Evaluate the concern and apply appropriate containment where required.
Coordinate corrective, recall, or regulatory actions where applicable.
Product quality and patient safety are closely connected. EndoCare+ maintains pharmacovigilance processes for receiving, documenting, assessing, and following up safety information relating to its products.
If you need to report a product quality concern or a suspected adverse event, please use the dedicated reporting channels below. Providing relevant product, batch, event, and contact information helps our responsible teams assess and follow up the report appropriately.
Report concerns related to product quality, packaging, labeling, appearance, suspected defects, or other product-related quality issues.
Report Product QualityReport a suspected adverse reaction or other safety-related event associated with an EndoCare+ product.
Report an Adverse EventFor serious or urgent safety concerns requiring immediate escalation, contact our Pharmacovigilance function through the designated safety contact.
Pharmacovigilance Manager: Khairallah Yahya
Safety Hotline: +967 784444699