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Billev Pharma East was established in Ljubljana 2007. The company was at that time a sister company to Billev Pharma ApS, Denmark with the same owner. The owner Peter de Mayo Billev established Billev Pharma ApS as one of the first regulatory affairs consultancy companies in Europe in 1978. Since the very beginning, it has been our vision to be early to provide assistance with the growing amount of new legislation through active participation in the preparatory work for rules and regulations through international organisations. This is what has made it possible to give fully up to date consultancy to our customers. Through diligent consultancy work, Billev Pharma East has since its beginning in 2007 slowly grown to its present size also due to loyal customers. We are building our present services to our customers on this foundation. Therefore, we offer you scientific solutions with beneficial impact on your business processes to gain competitive advantages.

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“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.


“FOCUS ON PATIENT SAFETY” also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. It started with Pharmacovigilance for human medicinal products, however due to various safety experiences with different products and interactions the expectation for safety monitoring lies also with all other products: - Pharmacovigilance for veterinary medicinal products, - Vigilance for medical devices, - Cosmetovigilance for cosmetic products - Nutravigilance for food, dietary supplements, or medical food Therefore there is or should be a common objective for pharmaceutical industry, competent authorities and health care professionals to raise awareness about safe use of all products, to gain profound knowledge about these products and to prevent serious adverse events.


“NEED FOR EFFICACY AND SAFETY OF THE PRODUCT” Medical writing of regulatory documentation: - Clinical Overview and Summary (all legal basis applications) - Non-clinical Overview and Summary (all legal basis applications) - Clinical Study Reports (CSRs), protocols, Investigators brochures (IBs), safety narratives - Enviromental Risk Assessment - SmPC, PIL - Bridging reports (readability) - Writing of medical / pharmaceutical publicatons for journals Medical writing in Pharmacovigilance: - Company Core Data Sheet, Company Core Safety Information - Periodic Safety Update Reports (PSUR / PBRER) - Risk-benefit reports - Signal detection - Risk Management Plan (RMP) - Medical assessment of adverse drug reactions - Medical Enquiries Medical advising / promotional activities: - Pre – or post – launch strategic medical/scientific advising - Advising on promotional scientific content and communication plan - Communication with key opinion leaders on behalf of the customer


“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.

Zadnje novice o podjetju


Upgrading the electronic business of the company

Zadnja realizacija ・ 6. avg. 2022 preberite več Open In New icon

The company BILLEV PHARMA EAST D.O.O. was selected in the public tender for: Establishment or upgrade of electronic business in the company in the period 2019–2022 “E-BUSINESS 2019–2022”. Financial support: The amount of the grant received for the purpose of the operation is € 29,995.00. The purpose of the project is to establish or upgrade e-business In the company BILLEV PHARMA EAST D.O.O., we implemented five different measures within the project, which strengthened our operations and promotion in foreign markets and facilitated the communication with our customers and partners. The implemented measures are: - electronic exchange between partners; - digitization of appearances at fairs; - websites for foreign markets; - product sales video; - competence building and training.


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  • Zdravila
  • regulatory affairs
  • pharmacovigilance
  • medical consultancy
  • quality
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