Life Cycle Management

Managing through development, validation, production and supply

Dishman Carbogen Amcis Ltd recognizes that managing the entire life cycle of a drug substance (API) from development to validation and onwards to commercial manufacturing is important to many of our customers who want to avoid multiple technology transfers between vendors and the associated risks.

Our experienced project managers are constantly evaluating how to positively impact our products and services' environmental, health, and safety aspects while enhancing course supply chain efficiencies and ultimately improving time to delivery.

Risk Mitigation

Risk mitigation plans for KRMs (key raw materials) are key fundamental living documents, routinely reviewed and updated to ensure that focus remains on products through their life cycle. Second-generation routes are explored in conjunction with our clients, ensuring that there is complete clarity within the project team around opportunities to improve the process as the compound matures in the market. Risk mitigation plans for KRMs are also a key consideration that is routinely reviewed and updated to ensure that focus remains on products throughout their life cycle.

Evaluation

Dishman Carbogen Amcis Ltd has the ability to backward integrate KRMs, either through group company resources or with external qualified partners.

We have a well-developed system of evaluating and monitoring key process performance data during routine manufacturing, including statistical data to ensure that we can clearly assess the implementation of any process improvements for quality, cost, time, and benefit parameters with a complete understanding of process performance.

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