celares GmbH is committed to innovative, high-quality custom PEGylation tailored to your individual requirements.
celares GmbH is an international high technology service company in the field of drug delivery for biopharmaceuticals. We provide development and as well production services to leading, innovative pharmaceutical and biotechnological companies and research institutions. Because of the high quality demands in the development of pharmaceuticals we have elaborated this Quality Statement that we believe will satisfy customer inquiries regarding our quality system and test certification. celares GmbH understands the need for continuous improvement.
Our Quality Policy is to develop, produce, and deliver on time products and services that meet or exceed customers’ expectations. celares GmbH is committed to combine innovation and flexibility with the need for high quality standards. In order to do this, we have implemented a quality system with processes that are continuously being improved to satisfy our customers’ changing needs.
celares GmbH offers both development and production services. For the development site, management of materials, equipment and resources, development services, and documentation are performed in a GMP like manner as far as applicable.
In its production facility celares produces high quality activated PEG or other polymers. For our production site GMP is established on the basic requirements for Active Substances used as Starting Materials according to EU-GMP-guideline part II. Even though, a manufacturing authorization is not needed for the products of celares, the need for GMP inspections by the customers is well understood by us.
Product and Service
celares GmbH is committed to providing our customers with superior quality, and we have implemented a quality system to assure this. We place a strong emphasis on quality by design and take preventive actions to build quality into our processes and products. By involving customers in this process, we are able to prioritize their requirements and prevent deviations in our performance. All our services and products are provided according to celares’ specifications and undergo testing to assure conformance. Additional test verifications are included to assure compliance with unique customer specifications when requested.
Continuous Improvement and Customer Satisfaction
Continuous improvement at celares GmbH has become a way of life. Together with our customers our highly motivated employees at celares GmbH constantly evaluate and improve the performance of company processes, and process and development capabilities.