We know that moving a candidate drug product through the subsequent phases of clinical development as quickly as possible is one of your top priorities. To achieve this objective, our highly experienced staff can support the expedited development and manufacture of investigational medicinal products for all stages of clinical development. In our cGMP facilities, we can handle various batch sizes and active substances in the highest occupational exposure bands (OEB5), and our capabilities for polymer-based drug manufacturing are unique. Having versatile, fully qualified extrusion equipment in place makes the difference in maintaining timelines. Building experience and capabilities in this field take many years – with us, you will immediately be on the right track.
Next to being up to speed in development, we have an excellent track record in quality-related matters, including inspections by regulatory authorities such as the FDA. Procedures for ensuring the appropriate level of cGMP for the different phases of clinical development are maintained by our Quality Assurance team.
In connection with your clinical trial, we can perform stability studies according to ICH guidelines. You will receive regular updates on the resultant stability data, which can be used to support the shelf-life of your product. After the stability study, you will receive a full report to be used as supportive documentation for filing your product.
In short, our flexible and efficient approach means you will receive your clinical supply in the most time- and cost-effective way while knowing that the right level of quality is achieved.
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