During 2009, DEMO S.A. completed its biggest investment to-date in equipment and premises allowing the company to enter new markets within the pharmaceutical industry.
Our current production capabilities span through all different types of products used in hospitals.
DEMO S.A. is also representative in Greece of major companies such as Nipro, Istituto Grifols, Apotex, GSK, Addmedica, Novartis, Bellco, Pharmacosmos, SANDOZ, expanding this way the range of products that offers to health professionals and ensuring the best possible treatment for the patient.
Based on its expertise, its modern equipment and its cooperation with world’s leading companies, DEMO SA also offers the following services:
Having warehouses fully equipped and organized in accordance with the storage standards of pharmaceutical products, DEMO S.A undertakes the handling of other companies’ medicines.
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 asMHRA, 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 -the physicochemical and microbiology-, may control on behalf of third parties all raw materials, packaging materials, intermediate and finalized products to ensure that each batch of product placed on the market, complies with the strictest quality standards.
Housed in facilities of a total area of over 1,500 m2, is equipped with modern, analytical instruments and is staffed with highly trained staff of most scientific disciplines. The primary objective of the department is to conduct analysis in the most reliable manner.
For this purpose the quality system applied to the laboratories of DEMO is fully consistent with the guidelines of the Principles of Good Laboratory Practices (GLPs), International Standards (ISO / IEC guidelines) and international organizations (e.g. WHO), with particular emphasis in recording and maintaining all raw data and mainly on the use of equipment and software compatible with the requirements of the strictest law principles.
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 9001:2008, ISO 13485:2003, DY8 / from 1348 to 1304.
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.
- the selection and purchase of equipment
- the launch of the production unit
- the design and construction of:
- Medicines production plant
- Medicines Quality Control Unit
- Storage Facilities