Quality & Compliance
Regulatory Position - WDA(H) Application Status
Cernex Pharma’s facilities, SOPs, and systems meet MHRA GDP requirements.
Cernex Life Sciences Ltd is currently progressing an application for a Wholesale Dealer Authorisation for Human Medicines (WDA(H)) with the Medicines and Healthcare products Regulatory Agency (MHRA). This application reflects our transparent compliance intent and our commitment to operating within the UK’s rigorous regulatory framework for pharmaceutical distribution.
We do not hold ourselves out as fully licensed where authorisation is pending. We communicate our regulatory status clearly to all partners and operate interim protocols that align with anticipated WDA(H) requirements.
Supply Chain Integrity
Good Distribution Practice (GDP)
All storage, handling, and distribution activity is conducted in adherence with Good Distribution Practice guidelines consistent with UK and European standards.This includes controlled storage conditions, monitored temperature ranges, and documented handling procedures at every point a product is in our custody.
Client Qualification
Before any transaction proceeds, both suppliers and customers are subject to due-diligence qualification checks: a Know Your Supplier (KYS) and Know Your Customer (KYC) process designed to confirm legitimacy, licensing status, and authorised trading activity on both sides of a transaction.
Counterfeit Prevention
Batch-level traceability is maintained from point of origin through to final delivery. Verification protocols are applied to confirm that products move through authentic supply channels, with serialisation and batch documentation checked at each handover point to reduce the risk of falsified product entering the chain of custody.
Cold-Chain & Logistics
Temperature-sensitive products are monitored continuously in transit, with data-logging maintained across both standard cold-chain range (+2°C to +8°C) and controlled room temperature range (+15°C to +25°C), depending on product requirements. Logging records form part of the documentation provided at destination delivery.
Risk Management
Cernex Pharma maintains mock recall procedures to test the speed and completeness of our traceability systems, alongside escalation protocols designed to ensure that any product quality or safety concern is identified and acted upon without delay.
Anti-Bribery & Ethics
We operate a zero-tolerance policy towards bribery and corruption, in alignment with the UK Bribery Act. This standard applies across all supplier relationships, customer engagements, and third-party logistics partnerships, in every market in which we operate.
- Due diligence on intermediaries, agents, and local representatives
- Mandatory anti-bribery training for all personnel engaged in international trade
Trust Built on Absolute Integrity.
We do not pursue business opportunities that require compromise of our ethical standards. We reserve the right to terminate relationships with any partner found to have engaged in corrupt practices.
Quality Assurance, our quality management system includes defined escalation pathways for quality concerns, adverse events, or regulatory notifications.
+44 (0) 33 3123 4558
