Services

The Regulatory Affairs Department of our company can undertake on behalf of third parties the submission of eCTD files of pharmaceutical products through national procedure, mutual recognition or decentralized procedure, in Greece and in foreign countries. It also undertakes the maintenance of these licenses through procedures of amendment and renewal.

Moreover, it can be in constant communication with the pharmaceutical authorities to effectively monitor each case and to ensure the timely completion of the national phase procedures in each country.

It is continuously updated on the current legislative requirements and ensures that the company’s products are in accordance with them, while it is responsible for managing the l inquiries from Authoriteis such as MHRA, BFARM, SFDA and other authorities within and outside the European Union.

Our company’s Regulatory Affairs Department is staffed with experienced and trained personnel from various related subject disciplines.

Our Quality Control Department, consisting of two distinct laboratories –physicochemical and microbiological-, may control on behalf of third parties all raw materials, packaging materials, intermediate and final products, to ensure that each batch of product placed on the market complies with the strictest quality standards.

With facilities occupying over 2.500 m², Quality Control is equipped with modern analytical instruments and staffed with highly qualified and trained personnel of most scientific disciplines. Quality Control’s primary objective is to provide highly accurate and reliable analyses.

To this end, quality system applied to DEMO’s laboratories is fully compliant with the guidelines of Good Laboratory Practices (GLPs), International Standards (ISO/IEC) and international organizations (e.g. WHO). Particular emphasis is placed on documenting and maintaining raw data and on the use of equipment and software in line with requirements of the strictest legislative authorities.

Our Quality Assurance Department can undertake on behalf of third parties, the continuous monitoring of all production and control activities of a company, while ensuring strict compliance as to the applicable standards GMPs, GDPs, ISO 9001, ISO 13485, ΙSO 14001:2015, ISO 45001:2018.

Among the activities of the Department is the detailed design of new production areas, in accordance with the requirements of legislation and the inspection of critical partners of the company, in order to ensure constantly high quality of service. It is based on three principles prediction, proper planning and continuous monitoring.

The Department is staffed with experienced scientists of most specialties and is one of the most staffed quality assurance departments in Greece.

The Quality Assurance Department has achieved to combine the different requirements of universally valid laws of pharmaceutical product and to integrate them smoothly into its quality system.

With highly skilled staff, we ensure quality, large production capacity and prompt delivery of products.