Life sciences

AVL provides a comprehensive and specialized practice in industries related to Life Sciences.

Our client portfolio includes companies engaged in the production of pharmaceuticals, medical devices, diagnostic products, over-the-counter products, food production and marketing, cosmetics, and other consumer goods, agrochemicals, pharmacies, and medical professionals.

In the dynamic and multidisciplinary field of Life Sciences, the convergence of law and scientific innovation is crucial for navigating the ongoing ethical, regulatory, and commercial challenges. Our approach focuses on providing expert and strategic advice to businesses, academic institutions, and government organizations operating in this sector.

The area encompasses a wide range of disciplines including biotechnology, pharmaceuticals, medical devices, cannabis, food and beverages, regulatory matters, and more. Our practice is dedicated to understanding and applying the complex laws and regulations affecting these fields, ensuring regulatory compliance while facilitating innovation.

Our services include advising on commercial transactions, drafting licensing, collaboration, and distribution contracts, and representing clients in legal disputes. Additionally, we provide strategic guidance on regulatory compliance, including dealings with regulatory agencies, and managing risks related to safety, sensitive personal data protection, intellectual property protection in this field, obtaining mandatory health registrations and notifications, pricing, and more.

Our commitment goes beyond merely assisting clients with complex legal issues; it also involves promoting ethical and responsible advancement in Life Sciences. This includes staying informed about the latest technological and regulatory developments and adapting legal strategies to support innovation while ensuring the protection of client interests and compliance with applicable regulations.

We have a team with a strong legal background in the sector, equipped to guide clients through a legally complex and ever-evolving environment.

The team is distinguished by its deep technical and scientific knowledge, strong skills in regulations, solid experience in intellectual property to protect innovations, the ability to manage risks and mitigations, an ethical approach to legal practice, effective communication and negotiation skills, and constant adaptability to technological and regulatory changes. Our professionals have extensive experience advising Life Sciences companies on the challenges specific to these industries and their interactions with competition authorities.

Our team is not only composed of lawyers but also includes experts in biochemistry and medical ethics. These strengths enable the team to provide strategic advice and rigorous regulatory compliance, ensuring a balance between scientific innovation, ethical responsibility, and the commercial objectives of their clients.

Learn about our firm's notable cases.

  • For over 10 years, we have advised a major pharmaceutical multinational on their day-to-day operations, including the negotiation of numerous distribution contracts, patient support program agreements, and contracts for the provision of medicines and medical devices with public and private entities.

  • We have obtained licenses for cannabis cultivation for one of our clients, which has enhanced their product development, hemp exportation, and, in particular, the legal cultivation and commercialization of hemp.

  • In the regulatory context, we have provided highly effective assistance in obtaining sanitary registrations and mandatory health notifications for hundreds of products, particularly pharmaceuticals, for clients from various countries, boosting the local market and facilitating foreign investment.

  • Through a complex and detailed strategy, we have achieved the reclassification of dozens of products to ensure their availability in the OCT and OTX markets.

  • We have provided comprehensive and complete advice to pharmaceutical companies on drug pricing processes, particularly for new and strategic medications.

  • We have represented several pharmaceutical companies in challenging price ceilings, achieving new prices that appropriately reflect the characteristics of the products.

  • We have advised various companies on biotechnology issues and measures for implementing relevant regulations.

  • We have handled numerous litigations before the relevant authorities in administrative and civil branches, achieving favorable results and preventing sanctions for our clients and the analysis of their products.

  • We have represented a pharmaceutical laboratory before administrative and judicial authorities to suspend several health registrations that were erroneously granted.

  • We advised a pharmaceutical laboratory to challenge the price ceilings imposed by the regulator on certain medications under the price-setting regime.
  • We advised leading pharmacy chains in Ecuador on State regulation of the sector.

  • We provide ongoing support to our clients regarding the use of personal data of their customers and stakeholders.

  • We have advised negotiating alternative contracting models with the State, including leases, loan agreements, and donations of medications, equipment, and medical devices.

  • We advise and support several pharmaceutical and medical device laboratories in various stages of public procurement processes.

  • We have advised several pharmaceutical laboratories on implementing programs for controlling and ensuring compliance with regulations regarding the advertising of medications and medical devices.

  • We advised a pharmaceutical laboratory in creating a scheme for medical representatives and advertising prescription medications.

  • During the COVID-19 pandemic, we implemented dozens of biosafety programs across various industries.

  • We provided advisory services to pharmaceutical companies in negotiating representation, agency, commission, distribution, and logistics operation contracts.

  • We successfully advised one of the leading distribution groups in an investigation by the Ecuadorian competition authority for alleged market power abuse.

  • We advised a pharmaceutical laboratory on their entire scheme for agency, distribution, and pricing of their products in Ecuador.

  • We have advised a pharmaceutical laboratory on their product discount scheme, ensuring compliance with competition regulations and avoiding discriminatory or predatory practices.

  • We advised a pharmaceutical company in an investigation initiated by the competition authority concerning alleged refusal to supply products to public hospitals.

  • We provided advisory services to pharmaceutical laboratories and distributors in investigations regarding potential collusive agreements, price discrimination, and abuse of power before the competition authority.

  • We advised leading pharmacy chains in Ecuador during investigations into complaints of price discrimination and exclusive distribution.

  • We successfully advised several pharmaceutical companies in an investigation for alleged unfair practices in drug labeling.

  • We have implemented more than a dozen preventive audits and competition compliance programs in the pharmaceutical, food, and logistics industries, among others.

These cases highlight the importance of specialized and up-to-date legal advice in a sector where the intersection of scientific innovation, intellectual property rights, and regulatory norms is crucial for the success and protection of the parties involved.

When is a lawyer needed in Life Sciences?

  • A company or individual might need a lawyer specialized in this field when facing challenges such as the development and commercialization of new pharmaceutical products or medical devices, which require strict compliance with regulations such as those from the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA). It is also crucial for protecting intellectual property, sensitive personal data, and safeguarding inventions and employees, as well as defending against infringement cases. In situations involving litigation over adverse product effects, regulatory disputes, or commercial transactions such as mergers and acquisitions in the sector, an expert lawyer can ensure regulatory compliance, mitigate legal risks, and effectively defend the company’s interests.

What services does AVL provide in this area?

  • Advice on obtaining, suspending, and terminating sanitary registrations, mandatory health notifications, operating permits, and other certifications from the relevant authority.

  • Categorization of medications and setting of price ceilings.

  • Management of administrative litigation related to sanctioning processes initiated by authorities for alleged non-compliance with regulations.

  • Contractual analysis of distribution, manufacturing, licensing, and other documents necessary for business development or mergers and acquisitions.

  • Obtaining licenses for the cultivation, commercialization, distribution, and production of goods containing CBD.

  • Training for compliance with major regulatory standards in the pharmaceutical industry, for both medications and medical devices.

  • Advisory on the use of patient personal data and informed consent.

  • Training and advice on the advertising and communication of medications and medical devices.

  • Advice on the framework for requesting drug pricing.

  • Advice on the scheme for medical representatives and advertising of prescription and over-the-counter medications.

  • Advisory on managing information that can be communicated through channels such as social media, medical conferences, and laboratory visits regarding non-over-the-counter medical devices.

  • Advisory on entering into agreements with public and private institutions for patient support programs and other collaborative programs with institutions in the Comprehensive Public Health Network (Ministry of Health, Ecuadorian Institute of Social Security, ISSPOL, ISSFA, various SOLCA branches) [Ministerio de Salud, Instituto Ecuatoriano de Seguridad Social, ISSPOL, ISSFA, Sociedad de lucha contra el cancer SOLCA]

  • Development of internal compliance programs.

  • Advisory on verifying and ensuring compliance with local and international compliance standards and internal company guidelines.

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