How can we help you?

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Clinical evaluation

• Comprehensive consultancy in the field of conducting clinical evaluation.

• Drafting contracts for clinical trials.

• Negotiating with researchers, centers and CRO.

• Preparing and reviewing clinical trial documentation.

• Advice on obtaining permits and opinions necessary to conduct a clinical trial.

• Advising on the protection of personal data collected in the course of clinical trials

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Conformity assessment

• Advice on authorisation and notification of a notified body.

• Advice on the classification and qualification of the product.

• Advice on labelling and instructions for use.

• Support in the process of obtaining a certificate of compliance.

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Placing on the market and use

• Comprehensive support for the manufacturer and the authorised representative in reporting the product to the President of the Office.

• Comprehensive support for the distributor and importer in notifying the President of the Office of putting into service.

• Introducing changes to the data covered by the notification.

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Financing from public funds

• Help in building a market access strategy.

• Representation in reimbursement proceedings, including negotiations with the Ministry of Health.

• RSS development.

• Legal representation in disputes with the National Health Fund and the Ministry of Health.

• Consultancy in the field of procurement orders.

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Marketing

• Comprehensive legal support in conducting advertising campaigns.

• Legal evaluation of marketing materials.

• Drafting contracts with service providers.

• Preparation or evaluation of internal procedures regarding marketing activities addressed to medical professionals, including adapting procedures to national and European codes of good practice (MedTech Europe).

• Advice on umbrella branding.

• Advice on the protection of personal data.

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Distribution

• Negotiating and drafting distribution agreements.

• Development of distribution models.

• Consultancy and representation in the field of public procurement.

• Export support, including obtaining a certificate of free sale.

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Safety and quality

• Legal support for activities related to medical incidents (e.g. FSCA).

• Advising on internal procedures related to safety.

• Support in relations with the President of the Office.

• Advice on recalling a product from the market.

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Compliance

• Preparation or evaluation of internal procedures concerning:

  • marketing activities targeted at medical professionals,

  • tenders, including tender communication,

  • quality defects of products and product recall,

  • transparency of activities and anti-corruption policy,

  • response in the event of an inspection,

  • protection of the company's intangible assets,

• Audits of planned or ongoing research or educational projects.

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Relations with public administration

• Representation in proceedings before the Ministry of Health, URPL, UOKiK or other authorities in cases concerning, among others:

  • placing on the market and use

  • advertising activities carried out

  • distribution models used

  • suspending or recalling a product from the market

  • practices restricting competition or infringing collective consumer interests

• Stakeholder representation in discussions with decision-makers.

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Relationships with competitors and patients

• Disputes with competitors:

  • within the scope of infringement of rights under patents, SPC, trademarks or other rights on intangible property

  • in the field of acts of unfair competition

  • in the field of industry codes

• Drafting technology transfer agreements, permits, license agreements and other commercial agreements.

• Responsibility for a dangerous product (medical incidents).

• Management of crisis situations.

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Legislation

• Representing industry organizations in the legislative process.

• Legislative monitoring.

• Creating reports and legislative proposals.

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Implementation of EU Regulations

• Adjusting the company to new regulations.

• Preparation or evaluation of internal procedures.

• Conducting trainings.

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