Product transfers are not easy and will be handled with care and a dedicated team of interdisciplinary specialist. Whether we have developed a formulation for you or you bring a semi final or final formulation to us, a highly experienced team will take care of you.
The formulation comes from an external development partner or manufacturer? Our specialists will be by your side, evaluating the formulation, even visiting the third party and work together with them to transfer your formulation, analytical methods and the manufacturing process to our equipment. Headed by an expert for late stage development and registration, the team uses sophisticated internal procedures according to cGMP to ensure compliance with governmental regulations.
Our product launch team will make sure that together with your experts we will finalize the product art works for secondary packaging and schedule the manufacturing of the launch batches. Experienced in handling a high number of SKUs for a product we can offer you a high flexibility when it comes to dosage strengths, pack sizes and number of target countries.
Situated in Hamburg, the production site covers the complete supply chain you need to bring your product into the market. Customer management is ready to take your forecasts, orders and manages the artwork process. Procurement makes sure all excipients and the API are at the ready when the production slot comes up. State of the art manufacturing equipment from specialized mixing vessels, over customized coating and drying equipment to high speed converting and secondary packaging is ready to manufacture your product. We will ensure that you will receive the amount you need.
The quality control department located at the manufacturing site is able to test in-process controls intermediate products and the finished products in a state of the art laboratory using the latest analytical test systems. Test methods optimized for speed and precision will make sure that a specification compliant product is manufactured.
Overseen by the quality management department all activities whether it is the sourcing of raw materials or the manufacturing, testing and distribution of the product all is planned and executed according to current regulatory requirements. Periodic inspections and audits from customers and governmental authorities make sure that all processes and procedures comply with the latest GMP requirements.
All our lines are serialized.