Emdoka has an own chemical-pharmaceutical laboratory which is equipped with state of the art equipment. A well-trained group of laboratory assistants, directed by the latest (V)ICH and EMA guidelines, is continuously working in the following fields:
- analytical method development
- analytical validation
- pharmaceutical formulation development
- active assistance during upscaling processes
- validation of industrial processes
- stability studies
An academically educated registration team is planning, outsourcing and directing all pharmaco-toxicological, clinical and ecological studies, required for the Market Authorizations.
Furthermore, this team is responsible for the regulatory approvals of the newly developed products and for the lifecycle management of the already existing Marketing Authorizations, such as PSUR submissions, five yearly renewal and variation procedures.
Emdoka’s product portfolio consists of different types of formulations, such as oral powders, and -solutions, injectable solutions and -suspensions, dermal sprays and -solutions, tablets and boluses.All these different formulations are manufactured by specialized partner companies. Each of these partner companies is located in the EU and is GMP-certified by its national authorities.
The primary and secondary packing of commercial products is tailor-made according to the specific demands of each sales partner.
In order to have a constant monitoring of the quality of its veterinary finished products as well as of the laboratory output, a quality system following the most recent pharmaceutical guidelines is adopted.
The distribution of products from Manufacturer to Distributor is performed according to the principles of Good Distribution Practice (GDP). A GDP accreditation is obtained from the Belgian Federal Agency for Medicines and Health Products (FAMHP).
This strict quality policy guarantees the high quality of the Emdoka products: from its design on, up to the actual delivery at the warehouse of end users.