Pharmaceutical law

The “EXPERT SM” company provides the following services in the field of pharmaceutical law:

  • assistance in registration of medicines, medical equipment and medical products;
  • legal advice on advertising of medicines, medical equipment and medical products;
  • methods of promoting medicines: development and legal support of sales schemes;
  • drafting and legal analysis of commercial agreements, including distribution agreements and co-marketing agreements;
  • drawing up and legal analysis of contracts for the processing of customer-supplied raw materials and bringing standard forms of such contracts into compliance with the legislation of Azerbaijan;
  • legal regulation of foreign trade activities;
  • legal regulation of foreign trade activities;
  • consulting on issues of liability for the release of substandard products;
  • consulting on clinical drug trials;
  • legal support of clinical trials, including:
  1. a) development of a legal scheme for financing clinical research;
  2. b) support of issues related to the import of investigational drugs and other materials (test tubes, reagents, equipment, etc.). Support of issues related to the export of samples, etc.;
  3. c) development of contracts:

— with a clinical base (a medical institution that conducts clinical trials)

— with researchers (doctors)

— with the subjects (consent form for participation in research)

— insurance

— to provide expert services from government agencies authorized to monitor and record research results

  1. d) cooperation with health authorities on the conduct of clinical trials.
  • protection of intellectual property rights;
  • representing the client’s interests in connection with violation of patent rights and trademark rights;
  • legal assistance in developing effective structures for the import and distribution of medicines, medical equipment and medical products, maintaining their consignment sales stock, aimed at maximizing the use of customs and tax benefits applicable to the pharmaceutical industry;
  • representing and protecting the interests of clients before customs authorities, both in pre-trial procedures and in courts;
  • representing and protecting the interests of clients before tax authorities, both in pre-trial procedures and in courts;
  • debt collection from Azerbaijani distributors, including in court and by initiating bankruptcy proceedings;
  • development of draft regulations regulating healthcare;

 

As well as general legal services:

  • legal consultation;
  • registration of companies with foreign investments (the investor is not a citizen of the Republic of Azerbaijan);
  • registration of representative offices and branches;
  • drafting and legal analysis of contracts;
  • legal outsourcing (subscriber legal services);
  • accounting outsourcing (accounting services for companies);
  • representing the client’s interests in courts of various instances;
  • liquidation of local companies.

Our company’s partner in the field of pharmaceutical law is the Legal Alliance company, a leader in the Ukrainian legal services market in the field of medical and pharmaceutical law, according to the eighth edition of the reference book “Ukrainian Law Firms 2010. A Handbook for Foreign Clients” (“Ukrainian Law Firms 2010. Handbook for foreign clients”).

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