Where do we add value?

We add value throughout the entire product life cycle.

  • strzałka prawo
  • strzałka lewo
  • Launch produktu strzałka prawo
  • Komercjalizacja produktu strzałka lewo
  • Rozwój produktu po launchu strzałka prawo
  • strzałka lewo
  • strzałka prawo
  • 1. Concept and product research

    We support the process of developing the concept of a medicinal product and conducting research. At this stage, we develop agreements for conducting clinical trials or cooperation agreements in the field of product development.

    We also deal with protection of intellectual property rights to a new product (in cooperation with patent attorneys) and obtaining regulatory exclusivity. We consult initial product development plans in the context of market access strategies and marketing strategies.

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  • 2. Launch preparation

    We are with our clients during the entire process of preparation for launching products. Together, we develop the concept of launching, taking into account business assumptions, regulatory requirements, reimbursement rules and intellectual property rights.

    We have experience in working on national and EU-wide strategies. We prepare market access projects for original, generic, biological, biosimilar, NBCD, and orphan drugs. We support obtaining a reimbursement, we create defence strategies if necessary, and advise on selecting the product name.

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  • 3. Product launch

    We support clients in product launch activities, ensuring that all legal aspects of the first delivery process are taken care of.

    We support clients in contacts with regulatory authorities, represent clients in contacts with market competitors, and perform legal verification of advertising materials and promotional campaigns.

  • Launch produktu strzałka prawo
  • 4. Product commercialization

    We provide support for the product commercialization process at every stage of the supply chain – from the manufacturer / importer, through a wholesaler, to a hospital or pharmacy. We advise both on the rules of trading and setting prices. We prepare sales, delivery, and distribution contracts. We develop trade policies.

    We support clients in the legal aspects of advertising medicinal products. We provide legal protection of clients’ interests in case competitors act unlawfully. We prepare new market strategies for products in the event of a change in the market situation (e.g., entry of competition, change of reimbursement conditions).

  • Komercjalizacja produktu strzałka lewo
  • 5. Post-market product development

    We support projects for the development of products already present on the market, including, for example, product line extensions, adding new indications, changing the registration status.

    We advise on introducing changes within the product reimbursement scheme.

    We take care of the legal aspects of product development since its market launch.

  • Rozwój produktu po launchu strzałka prawo
  • 6. Product quality and safety

    We advise on all issues related to product quality and safety.

    We support the processes of product withdrawal or recall, crisis management in connection with quality defects or product shortages, as well as factory or warehouse audits and inspections.

    We provide support in the event of patient claims.

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  • 7. Completion of product commercialization

    We provide support for the process of finishing product marketing. We prepare arguments supporting shortening of reimbursement decisions.

    We analyse the possibilities of early termination of cooperation with contractors. We conduct product rights’ transfer or sale transactions.

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