In the rapidly evolving global environment of pharmaceutical sector, supply chain sustainability is a key factor of success and a competitive advantage.
Logistics and Supply chain services, incorporated in all stages of the development process are provided in order to facilitate post approval commercialization of the finished products.
Our highly experienced team offers continuous support to our clients throughout the lifecycle of their products ensuring compliance with GMP standards & ICH requirements while implementing lean manufacturing principles.
More than 200 batches executed (registration and commercial) and more than 1 million packs of commercial products delivered within 2019.
We offer a wide range of services including:
- Supplier evaluation, qualification and sourcing for APIs, excipients and packaging components
- CMO identification, qualification and terms negotiation based on the manufacturing process requirements, optimal batch size, capacity and cost
- Production planning & Project management throughout the development process
- Launch coordination in order to minimize lead-time post-MA grant
- Customer service in commercial phase(artwork management, on-going stability reports & PQRs)
- Supply chain mapping for APIs and finished products managing dispatches and deliveries OTIF
- Coordination of serialization process
- Post-approval support and resolution of any sourcing/quality issues or regulatory updates that can affect supply chain continuity.
- Inventory management minimizing stock levels while maximizing operational performance
We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes.
Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines.
In applications for Generic and Generic Plus medicinal products, the concept of bioequivalence is fundamental.