How can we help you?

 

​Clinical trials

• 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.

• Legal support in the field of Good Clinical Practice.

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

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Registration

• Comprehensive legal support in the field of registration under the centralised procedure and national procedures (national, mutual recognition, decentralised).

• Introducing post-registration changes.

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Manufacture and import

• Advice on obtaining, changing or withdrawing permits.

• Legal support in the field of Good Manufacturing Practice.

• Preparation of draft production contracts.

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Reimbursement

• Help in building a market access strategy.

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

• RSS compilation.

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

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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 for marketing activities addressed to medical professionals, including adapting procedures to national and European codes of good practice.

• Advice on umbrella branding.

• Advice on personal data processed for marketing purposes.

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Wholesale distribution

• Advice on obtaining, changing or withdrawing a permit.

• Drafting distribution agreements.

• Consultancy in the field of ZSMOPL and NMVO.

• Consultancy and representation in the field of public procurement, in particular in the field of biological drugs and generic drugs.

• Legal support in the field of Good Distribution Practice.

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Pharmacy distribution and non-pharmacy turnover

• Advice on obtaining, changing or withdrawing a permit.

• Advising on proprietary and quantitative restrictions on the pharmacy market.

• Consultancy in the field of running an internet pharmacy.

• Advice on the prohibition of advertising of pharmacies.

• Drafting distribution agreements and lease agreements.

• Consultancy in the field of ZSMOPL and NMVO.

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Pharmacovigilance

• Legal services for PASS and PAES tests.

• Advice on pharmacovigilance procedures.

• Advice on recalling a product from the market.

• Support in relations with the URPL.

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Compliance

• Preparation or evaluation of internal procedures concerning:

  • marketing activities targeted at medical professionals,

  • tenders, including tender communication,

  • pharmacovigilance,

  • withdrawing products from the market,

  • 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, Pharmaceutical Inspection, URPL, UOKiK or other authorities in cases concerning, among others:

  • obtaining or maintaining the validity of permits or permits,

  • 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 parallel import / export,

  • in the field of industry codes.

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

• Responsibility for a dangerous product (side effects).

• Management of crisis situations.

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Legislation

• Representing industry organizations in the legislative process.

• Legislative monitoring.

• Creating reports and position papers.