Pharmaceutical serialization
Serialization solutions for drug safety and traceability
In the pharmaceutical industry, serialization is a crucial process to ensure product integrity and traceability. Implementing serialization systems not only combats drug counterfeiting, but also improves supply chain management and ensures compliance with global regulations.
Traceability of Ingredients and Finished Products: We offer solutions that enable traceability from raw ingredients to finished products. This ensures the safety, efficacy and regulatory compliance of medicines throughout the entire supply chain.
Real-Time Monitoring of the Cold Chain: Our real-time monitoring technology ensures that pharmaceutical products requiring specific temperature conditions are maintained in a controlled environment throughout the distribution process.
Regulatory Compliance Management: Our compliance solutions are the most comprehensive in the industry, allowing you to report to all global government agencies to ensure your business is compliant anywhere in the world.
Predictive Analysis: We use predictive analytics to anticipate and resolve potential supply chain issues, improving operational efficiency and reducing risk.
Transform your Pharmaceutical Supply Chain
At PDG Consultant, we are committed to taking your business to the next level with advanced digital solutions. Ready to optimize your efficiency and ensure regulatory compliance?
Key components of pharmaceutical serialization
Serialization: We assign unique identifiers to individual products and/or packages, providing a protected and unique identity to each item. This makes it easy to accurately identify and track products at all times.
Aggregation: We integrate serialized products into larger units such as boxes and pallets. Each added unit receives a code containing detailed information about the products inside, thus improving efficiency in inventory management and tracking.
Traceability: We create an indelible provenance for every ingredient and finished product. This allows supply chain actors to verify the safety, efficacy, legitimacy and regulatory compliance of products at every stage of the process.
Global Compliance
In an increasingly complex regulatory environment, our serialization and traceability solutions ensure your company meets compliance requirements in any global market. From DataMatrix and GTIN labeling to GS1 standards implementation, we are prepared to meet the regulatory demands of any country.
Examples of Regulatory Compliance:
- USA: Compliant with FDA and GS1 standards for full traceability.
- Europe: DataMatrix implementation and compliance with EU FMD directive.
- China: Using eCode and GS1 codes for detailed tracking.
Our services range from initial assessment and needs analysis, to strategy development, solution implementation, ongoing support, training, and compliance audits. With our solutions, your company will be equipped to meet the challenges of pharmaceutical serialization effectively and securely.
