Partners in - Uvoz izvoz

Mechanical installations are crucial to maintaining a suitable living space. Any room that is properly equipped with this type of technology will economically and efficiently maintain the temperature in all weather conditions and at the same time protect the room from moisture. With our partners, we can offer you mechanical installations such as heating, plumbing services and service: Excavations; stamping; levelling surfaces; demolition; construction of sewage drain; etc.

“BUILDING DOSSIERS NOT WALLS” Regulatory affairs environment can be very complex depending on the type of product. From our experience medicinal products are on the top of complexity. Many times we also face that certain products are borderline and our knowledge on different types of legislation certainly gives you assurance that your product will be placed on the market under the applicable legislative act. Very important is also establishment of Quality System in Regulatory Affairs, as the regulatory affairs is a key input to all other departments and partners who need the information for production, labelling, monitoring safety and last but not least promotional activities. Many recalls of the products from the market is due to insufficient communication on the last approved status with all stakeholders. We will make sure communication flow in your organisation will be written in the form of intelligible procedure to overcome time and budget consuming hurdles.

In the pharmaceutical industry, document and data integrity plays vital role during development and in maintaining the quality and safety of products once they are in use. Having control of data, especially in an era of advancing technology, remains one of the key requirements and challenges in our discipline. Data quality and integrity requirements have been defined by standards organisations and regulators in numerous guidance documents. In Billev pharma we have hands on approach to help our clients to manage their data in the most efficient way. Together with our partners we can provide a comprehensive set of services related to data and document management: - Analysis of your current IT landscape - Advise on implementation of new IT systems, including RIM and Document management systems - Regulatory data identification (from documents to organised data) - Data migration - IT validation - IT audits

“BUILDING DOSSIERS NOT WALLS” A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet your requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. WE OFFER YOU - Due diligence process - Project management and oversight - Establishment of Quality System in different departments: Quality Manual, Standard operating procedures, Working instructions, Trainings of personnel - Compliance with GxP guidelines - Overview and detection of key personnel in organizational structure - Performance of Audits (regular audits, pre-inspection audits) - Setting up appropriate Contractual arrangements and supervision - Establishment of Quality System is to ensure effective communication and information flow between internal and external partners, which has the key impact on overall business process and inspection outcome.

Each product presents a big challenge. While planning the production process and selecting the production procedures with innovative approaches we aim to ensure the lowest amount of input energy, time and material, and guarantee quality repeatability and minimum material discharge. We are aware of the need for constant learning, therefore we organise various forms of employee trainings and education events in the company. Teamwork and internal trainings are the means of transferring knowledge among ourselves. We also collaborate with external partners, companies and universities.