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Providing ongoing consulting for a global biopharmaceutical company on legal and tax aspects of conclusion of contracts with the Client’s counterparties, as well as on the legal requirements applicable to the Client's activities in Russia.
Ratings

ALRUD Law firm is repeatedly mentioned by the ranking among the leaders, and receives the highest recommendations on key legal areas. This year ALRUD has managed to broaden its presence in the rating.

Newsletters

Healthcare and Pharmaceutical Industry

As one of the recent developments attention is being increasingly focused on the growth of the level of responsibility of manufacturers of pharmaceuticals and service providers for the quality, state supervision over the activities of the entities operating in this sector has been strengthened, regulatory requirements and rules for the industry are being tighten up.

ALRUD Law Firm renders legal support to foreign and Russian companies in their entering Russian market, and provides general advice on the companies’ day-to-day activities. Our qualified experts advise on a wide range of issues including regulatory requirements for the participants of the pharmaceutical market, as well as on the contract law issues, participate in negotiations with clients’ contractors, take part in drafting of and agreeing on contracts (including distribution, supply, storage, marketing and other contracts), give advice on the issues of structuring of the product supply chain from the manufacturer to the patient.

ALRUD advises on different legal issues in pharmaceutical industry including:

Commercial issues

  • drafting of distribution agreements, agency agreements, agreements with medical officers, healthcare organizations, patients associations, marketing agencies;
  • development of effective franchising schemes;
  • formalization of relations in the process of manufacturing (contract manufacturing), inspection of quality of the manufactured product.

Regulatory  issues

  • matters regarding registration of pharmaceuticals; 
  • legal regulation of clinical trials;
  • regulatory legal aspects of activities of pharmaceutical and medical organizations;
  • advice on the price setting, execution of permit / license documentation.

Corporate issues

  • M&A, transactions on sale / acquisition of pharmaceutical companies or companies authorized to develop / manufacture pharmaceuticals, food supplements, due diligence;
  • corporate restructuring;
  • legal support of equity and debt financing;
  • incorporation and legal support of activities of joint ventures, strategic alliances and consortia.

Intellectual property and advertising

  • general legal compliance matters relating to intellectual property;
  • due diligence of existing owners of rights in the intellectual property held by the company;
  • building of IP portfolio for new products;
  • license agreements and franchising, including the issues of transfer and use of know-how; 
  • representation in Rospatent on the matters related to trade marks registration and granting patents, and in the Rospatent Chamber for Patent Disputes;
  • peculiarities of advertising of pharmaceuticals, medical goods and medical equipment (including  via Internet).

Dispute resolution

  • settlement of corporate disputes;
  • settlement of tax disputes; 
  • debt collection;
  • representation in court proceedings related to violation of rights in intellectual property including patent disputes.