About us, Our mission
In respect of pharmaceutical science, staying up-to-date with international studies, and holding knowledge of the products required by a pharmacy (sikalias pharmacy was our origin), Sikalias laboratories provide for human health with the products (pharmaceuticals, nutritional supplements, medical devices, cosmetics). Sikalias laboratories regulatory assistance contributes by quality and providing with larger markets for selling their products.
The study of nature, as well as the orientation towards quality and modern techniques, are embodied in our mission statement. The same is valid to our modern laboratory facilities of high technology.
Support for Pharmaceuticals, Nutritional Supplements, Cosmetics, Medical Devices, FSMP
About the building: Construction of one of the building was recently completed and includes the control of temperature, air pressure and humidity in the entire building.
About the equipment: The manufacturing and packaging equipment contained in laminar flow that ensure the control of the above factors.
The entire laboratories facility is GMP approved.
The forms produced include oral liquids, sprays and external use forms like creams and gels manufactured in fully automatic production lines.
The daily capacity is 1,6TN per day.
Research and Development
Product development depending on your needs and your target.
Specialized scientists work together to take healthcare a step further.
We execute every phase of the development process with the utmost care, including identification of reliable suppliers of active ingredients, realization of laboratory and industrial-scale trial batches, development and validation of analytical methods and stability studies.
The result of this activity is the state-of-the-art registration dossiers worldwide.
Regulatory Affairs support for the territory where the product is going to be distributed.
Highly experienced Regulatory Affairs professionals contribute significantly to the drug development process and secure an output of high quality, approvable Dossiers.
Regulatory Approvals for our products is the result to our Total Quality approach.
All of our activities are conducted with the greatest respect for the environment and we continuously improve our methods in this direction.
Even on our daily working practice, we care for the optimal use of recycling materials and mind for their efficient handling.
Quality - Quality Assurance / QA
Quality at Sikalias Laboratories is assured through QA (Quality Assurance), a system substantiated by a series of documents, in which the quality policy of our company is reflected. The Documentation System consists of quality assurance manuals, procedures and guidelines concerning the work in each department, and relevant forms.
The Quality Assurance System applied in our company is structured in such a way as to combine the application of the rules of Good Manufacturing Practices (GMPs) that govern the pharmaceutical industry and the application of the principles in the ISO 9001:2015, ISO 13485:2012, ISO 22716:2007 standards.
The implementation of the Quality Assurance System serves as an important monitoring instrument, capable of lending value to the daily work output. Each stage of the procedure from the selection of raw materials up to the production and storage of the final product, its promotion and distribution both in Greece and abroad, as well as the development and approval of new products, are subject to strict controls, thus ensuring that the high standards we have set are maintained.
Sikalias Pharmaceutical Laboratories committed to continuously improving the performance of the Assurance System:
a) by annually reviewing the implementation of the system in all Departments during which the aims and performances of the previous year are assessed and the target for the new year is approved by the Management, and
b) by implementing the annual program of internal audits in all departments during which the organization of departmental operation is monitored and all necessary measures taken so that there is continuous improvement in their performance.