Regulatory Compliance

GalentisThrough measuring, monitoring and analyzing our processes, Galentis is engaged in identifying, documenting and effectively managing the many significant steps necessary to meet customer regulatory requirements. Moreover, we work closely with our customers to meet their goals on every project, striving to continuously improve efficiency and performance.

Galentis was first inspected and approved by the Italian Health Authorities in 1995 and has since been successfully audited on a regular basis by major multinational research-based pharmaceutical companies. Over the years, Galentis has complied with cGMP requirements and has a long history of continuous improvement initiatives. Through investments in human resources and infrastructure, the company’s objective remains to satisfy and exceed the requirements of our customers. To this end, Galentis has successfully achieved certification of our Quality Management System, fulfilling the requirements of ISO 9001:2015 and ISO 13485:2016. These certifications are beneficial to customers across industries, and we are proud to offer this high level of compliance.

Furthermore, the Galentis’ Board of Directors, by resolution on 17 December 2015, adopted the Organizational Model, Management and Control, and named the Supervisory Body, according to Legislative Decree. N. 231/2001. It is another step forward for our company, in addition to ISO 9001:2015 and 13485:2016 certifications, to prevent the commission of crimes indicated in the said Decree, through the definition of the tasks, the traceability of decisions and system of sanctions provided for by the Model, helping to improve relationships within Galentis and between the company, its customers and its suppliers.

With more than 25 years of experience in chemical synthesis and the production of advanced pharmaceutical intermediates and other fine chemicals, Galentis is committed to providing our customers with the highest level of service. For reference, the company’s Organizational Model, Code of Ethics, ISO 9001:2015 certification, ISO 13485:2016 certification and Quality Policy documents are available below.


Galentis Model of Organization L.231 – English
Galentis Code of Ethics – English
ISO 9001:2015 Certificate – English
ISO 13485:2016 Certificate – English
Quality Policy – English
Galentis Modello di Organizzazione L.231 – Italiano
Galentis Codice Etico – Italiano
ISO 9001:2015 Certificato – Italiano
ISO 13485:2016 Certificato – Italiano
Quality Policy – Italiano