BILLEV PHARMA EAST

Slovenija

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BILLEV PHARMA EAST
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5 Izdelki

Slovenija

“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.

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Slovenija

“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.

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Slovenija

“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

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Slovenija

“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.

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Slovenija

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

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BILLEV PHARMA EAST

Tržaška cesta 202

SI-1000 Ljubljana - Slovenija

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