Services
Life Sciences
AVL offers a specialized full-service legal practice for the life sciences industry. Our client portfolio in this area includes manufacturers of pharmaceuticals, over-the-counter items, medical devices, and diagnostic products, as well as foodstuffs, cosmetics, other mass consumer goods, and agrochemicals. We also counsel and represent pharmacy chains and medical personnel.
Our services
Our services
With the challenges of a growing population, the demand for food has increased exponentially in recent years, raising new challenges for the food, seed, and agribusiness industries, not only from a business standpoint but from a regulatory one as well.
Biotechnology applications have undergone unprecedented development in recent years. At AVL, we know the challenges that biotech companies face, especially in the regulatory and intellectual property spheres.
Cannabis use has taken on a leading role in recent years because of its therapeutic benefits for a variety of pathologies. Dozens of countries allow its production and marketing. AVL has specialized in providing counsel to new ventures in this market, supporting them in obtaining permits for planting, processing, production, and marketing of cannabis-derived medicinal products.
AVL has formed a multidisciplinary work group to provide comprehensive counsel to our clients in managing the COVID-19 health crisis. The group has focused on offering crisis management strategies and implementing regulatory requirements, protocols, and approaches to address the impact of the pandemic.
We know the particular demands and challenges faced by companies engaged in medical device production, distribution, and marketing. AVL has extensive experience to offer in sector regulation, import processes, and medical device advertising and promotion, including marketing of medical devices in the private and public sectors.
Pharmaceutical companies are under new pressures and challenges worldwide; among them, their increasingly close relationship with health authorities, price regulation, reputational risks, the challenges of innovation, and the need to meet the demand for better therapeutic alternatives and solutions to new diseases.
Our lawyers have broad experience in the pharmaceutical sector. Besides knowing the applicable regulations, we understand the business. We know the commercial, regulatory, and bioethical issues our clients are dealing with.
We counsel our clients in all aspects of health service provision, from obtaining operating permits and complying with regulatory requirements to counseling on medical malpractice and personal injury cases.
Life science companies know they operate in a highly regulated environment worldwide. Our team of lawyers has far-ranging experience counseling on regulatory issues with government authorities.
Success Stories
- Represented a pharmaceutical laboratory before administrative and judicial authorities in the suspension of several wrongly granted health registrations.
- Counseled a pharmaceutical laboratory in challenging the price ceiling imposed by the regulator on certain drugs through a price setting system.
- Counseled the main pharmacy chains in Ecuador on state regulation of the sector.
- Provided ongoing support to our clients on the use of their customers' and stakeholders’ personal data.
- Counseled in negotiations concerning alternative State procurement models, including leasing contracts, loan and restitution contracts, and donations of medicines, medical devices, and equipment.
- Counseled and provided support to several pharmaceutical and medical device laboratories on the various stages of public procurement processes.
- Counseled a number of pharmaceutical laboratories on implementing programs for regulatory compliance and control regarding medical device and medicine advertising.
- Counseled a pharmaceutical laboratory on instituting a pharmaceutical sales rep program and prescription drug advertising plan.
- Implemented dozens of biosecurity programs in various industries during the COVID-19 pandemic.
- Counseled pharmaceutical companies in negotiating representation, agency, commission, distribution, and logistics operation agreements.
- Successfully counseled a major distribution group in an inquiry by the competition authority concerning alleged abuse of market power.
- Counseled a pharmaceutical laboratory on its entire agency, distribution, and product pricing framework in Ecuador.
- Counseled a pharmaceutical laboratory on its product discount program, ensuring that they comply with competition regulations and avoid engaging in discriminatory or predatory practices.
- Counseled a pharmaceutical company in an investigation opened by the competition authority on alleged refusal to supply products to state hospitals.
- Counseled pharmaceutical laboratories and distributors in competition authority investigations of possible collusive agreements, price discrimination, and abuses of power.
- Counseled the main pharmacy chains in Ecuador in a government inquiry into price discrimination and exclusive distribution complaints.
- Successfully counseled several pharmaceutical companies in an investigation of alleged unfair practices in medicine labeling.
- Implemented more than a dozen preventive competition audits and compliance programs in the pharmaceutical, food, and logistics industries, among others.
