Servicio de gestión documentaria
We are assisting Apitoria Pharma Private against trademark oppositions filed by Apiter regarding the trademark APITORIA and its logo in class 5. The counterparty is a pharmaceutical company specialising in natural products and filed these oppositions based on its three trademarks APITER, APITER PROPOLEO-D, and APIFORT APITER, and its respective logos in class 5.
Apitoria is an Indian pharmaceutical company and wholly owned subsidiary of Aurobindo Pharma Limited. It is a prominent player in the pharma industry, particularly in the production of active pharmaceutical ingredients (APIs). As a leading generic API company, Apitoria has a significant share of the international pharmaceutical market.
Monica Germany
Not applicable
We provide legal assistance to Kalexius regarding Peruvian sanitary regulations including medical devices, SaMD, pharmaceutical establishments, regulation of the network of laboratories for quality control of medicines and related products in the health sector, veterinary products, agrarian products, transportation of hazardous materials and wastes, clinical trials, among others.
Martin Serkovic
Not applicable
We advised Key Peru regarding the non-authorized use of the sanitary registrations of certain products. The review of the case involved designing the best strategy of a complex situation as the authorization granted by our client was being wrongly exploited. Such strategy involved the analysis of the actions that needed to be conducted to prevent any sanction from the sanitary authority.
Martin Serkovic
Not applicable
We provided legal advice to our client regarding the proceedings established by the applicable Peruvian sanitary regulations of disposal and destination of medical devices and pharmaceutical products that have expired. For this effect, it was necessary to review the technical characteristics of the pharmaceutical products, as well as the legal framework regarding the necessary authorizations to follow the proceeding of the disposal of such products.
Martin Serkovic
Not applicable
We provided legal advice to Hospital Diospi Suyana regarding the renewal of its categorization license. Hospital Diospi Suyana is a modern high-tech hospital built for the indigenous Quechua people of the Peruvian Andes located in the district of Curahuasi, Apurimac. This hospital was founded in 2007 and has attended more than half a million patients, mostly Quechua speakers, with excellent facilities and state-of-the-art equipment.
Our intervention was performed before the sanitary authority of the regional government of Apurimac (a city located in the Andean region of the south of Peru) and involved an analysis of the the affirmative administrative silence that could be applicable to the Hospital’s request for categorization. In this case, the categorization had expired, and the team designed a strategy that involved the submission of a complaint before the competent sanitary authority due to the delay of more than 180 days to issue a statement. This was a successful case as, after submitting the complaint, the Hospital obtained satisfactorily the categorization.
Martin Serkovic
Not applicable
We advised Viña Tacama in on the extension of sanitary registrations, as well as on the renewal and cancellation on registrations that were necessary to conduct according to scheme of commercialization of products of the company. We have participated and analyzed our client’s commercialization scheme and strategy and accompanied in the review and mapping of sanitary registrations, as well as with the necessary technical documentation that would be required by the General Directorate for Environmental Health (DIGESA).
This has been a successful work since our client highly valued approaching the review of this assignment with a strategic partner perspective.
Martin Serkovic
Not applicable
We advised Viña Tacama in obtaining sanitary registrations in record time. For this matter, our team coordinated with the technical departments and supported them to design a sophisticated strategy before the sanitary authority, ensuring that no observations could be raised. This was crucial, as it was necessary to successfully obtain the sanitary registrations, given the commercialization plan to follow according to the company’s projections. Therefore, and in order to avoid any delay, detailed applications had to be submitted, ensuring that the registrations were obtained in due time. The competent authority (the General Directorate for Environmental Health -DIGESA) usually experiences significant delays due to the workload and the observations that may be pointed out in the context of these administrative proceedings. Nevertheless, in this case, no observations were pointed out by the authority and the administrative proceedings conducted to obtain the mentioned registrations were favourable.
Martin Serkovic
Not applicable
We are currently advising Pharmaris with respect to the request for the exchange of certain pharmaceutical products, since they do not proceed with its commercialization in due time. This is not a mandatory legal obligation of Pharmaris; notwithstanding, it is important to understand that the healthcare market of pharmaceutical products for complex diseases in Peru is a sensitive social matter. In that sense, Pharmaris is willing to find the legal means to collaborate with the public entity in granting additional products with a broad expiration date, notwithstanding that this is not expressly stipulated in the executed contract. We are providing legal advice to evaluate possible legal alternatives to comply with the company’s purpose.
Martin Serkovic
Not applicable
Ownership changes and port regulations. Our firm advised Trabajos Marítimos on a matter involving a change in shareholder ownership on the port’s classification and operations under the National Port System Law and its regulations. This required an in-depth review of the limitations imposed on private ports to ensure that the change did not disrupt ongoing operations.
Navigating port donations and regulatory requirements: We also assisted the client with potential donations to government entities, such as the Regional Government or Ministries, and whether such donations would require the surrender of the port’s authorisation or the aquatic usage rights granted by the National Port Authority (APN) and the General Directorate of Captaincies and Coast Guards (DICAPI).
Ensuring regulatory compliance for seamless port operations: Our firm provided detailed legal advice on both matters to ensure the continued operation of the port without regulatory complications. We played a critical role in helping the client navigate both issues to avoid potential disruptions to their port operations and ensure continued legal authorisation from the APN and DICAPI.
Peru’s leading nationwide port operator: Established in 1990, Trabajos Marítimos is the largest port operator in Peru, and the only company offering a full service package across the whole country.
Legal clarity for private port operators in Peru: This case is important because it clarifies the legal implications for private port operators in Peru, particularly when facing ownership changes and decisions about making donations to public entities. The case provides a clear understanding of the intersection between private port operations and public law, ensuring that regulatory compliance is maintained.
Latest development: We successfully completed the regulatory review requested by the client.
Patricia Castro
Confidential
Virgin Cruises’ expansion into Peruvian market. Estudio Olaechea is advising Virgin Cruises—an international cruise operator—on a plan to expand its services to the Peruvian market by offering travel packages through local intermediary companies. To ensure regulatory compliance, the client requested legal advice on how to navigate the legal landscape for tourism operators in Peru.
Regulatory review and compliance strategy: Our firm is reviewing the Travel and Tourism Agencies Regulations to identify the best course of action, including whether the client is required to register with the National Directory of Qualified Tourism Services managed by the Ministry of Tourism. We are providing the necessary guidance to ensure smooth market entry.
Negotiating with local intermediaries and analysing compliance roadmap: We are advising the client the client on the process of negotiating with local intermediaries and analysing the necessary steps to ensure compliance with local regulations.
Regulatory challenges for foreign cruise operators in Peru: This case is significant as it addresses the regulatory challenges faced by foreign companies entering the Peruvian tourism sector, particularly in the cruise industry.
Latest development: We continue to advise the client on the matter.
Patricia Castro
Confidential