DRONANIA disposes of an independent quality (asurance) management system. As member of the LAT Group Isolde Leidl heads the quality management department and the employees entrusted with the task at the DRONANIA premises.
The quality system involves the production and assessment of pharmaceuticals, food supplements, medical products and cosmetics in accordance with GMP rules, HACCP and cosmetic GMP.
Production procedures, storage and laboratory assays are subject to a critical and comprehensive risk management. This has been a prerequisite for the high quality of DRONANIA’s products both within their own portfolio and from contractors.
The responsible regulatory authorities (Government of Upper Bavaria, District Office Memmingen for food supplements, food and cosmetics) regularly check upon the compliance with quality standards.
If you want to assure yourself of our quality standards before placing a production order please do not hesitate to contact our directing manager, Dr. Wiedenmann (matthias.wiedenmann@dronania.de).
TEST SAMPLES:
Additionally, DRONANIA produces test samples according to the strict GMP rules in context with product development, for market research, stability tests etc. – either pharmaceuticals or food supplements. The core competence lies with herbal preparations in liquid and solid forms.
DRONANIA, furthermore, produces clinical test samples for projects within the LAT Group. In August 2009 the responsible regulatory authority in Munich gave the manufacturing approval according to § 13 AMG for liquid clinical test products for external use (also see News). As a result DRONANIA’s service portfolio as a production contractor and scientific partner has expanded to this new area. A further expansion towards other pharmaceutical forms is in prospect.
Planning, recipe production, packaging, blinding, preparation of necessary regulatory documents (IMPD), quality inspection and quality insurance – all aspects can be offered by the LAT Group.
Do you have any questions regarding our QM System or Contracting at DRONANIA?
Please contact Mrs Leidl (isolde.leidl@dronania.de)
