Life sciences in Mexico

Baker McKenzie Abogados, S.C.

A market stalwart, Baker McKenzie Abogados, S.C. is well regarded for its expertise in life science and advises industry leaders in the healthcare, pharma, cosmetics, chemicals and cannabis segments, among others. The practice advises clients in the fields of intellectual property, commercial litigation and dispute resolution in general, privacy and data security, foreign trade, litigation, antitrust and compliance. Founding president of the Mexican Association of Pharmaceutical and Sanitary Regulation, practice head Christian Lopez-Silva has considerable experience in the regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. Additional key individuals in the practice include José Hoyos, who provides support to industry clients on foreign trade, customs matters, and free trade agreements; along with Carlos Vela-Treviño (information technology and communications) and Marina Hurtado-Cruz (IP, health, advertising and consumer law). Civil and commercial litigator Juan Francisco Vasquez, who participates in disputes work in the sector, was raised to the partnership in July 2022; however, fellow former senior associate David Campos left the firm in September 2022.

Practice head(s):

Christian Lopez-Silva

Key clients

Pfizer

Merck Sharp & Dohme

Vitamedica

Bristol Myers Squibb

Biomarin

Chinion

UKDIT

Abercrombie

Estee Lauder

Parfums Christian Dior

Jafra Cosmetics

Takeda

Cargill

Beckton Dickinson

Sivantos

Troy Resinas

Bio-Rad

Work highlights

  • Advised Pfizer, Merck Sharp & Dohme and Vitamedica, on identifying current legal developments and critical issues converging in the area of digital health.
  • Advised Bristol Myers Squibb, Biomarin, Chinoin and UKDIT on navigating the international system of medicines procurement implemented by the United Nations Office for Project Services.
  • Advised Abercrombie, Estee Lauder, Parfums Christian Dior and Jafra Cosmetics, which all commercialize cosmetics in Mexico, on navigating institutional and legal changes in the regulatory system in Mexico.

Galicia Abogados S.C.

A stellar roster of clients in the pharmaceutical and healthcare industries turn to Galicia Abogados S.C. for advice on life science matters, from logistics to dispute resolution. Being a full-service firm, it has a highly specialised practice with experience regarding digital health, UNOPS and governmental procurement process; health care mergers, acquisitions and joint ventures; the regulatory aspects of the release, sale, labelling, promotion, advertising and distribution of medicines, medical devices and human vaccines; along with the drafting and negotiation of agreements and regulatory data protection. Co-leading the practice, Bernardo Martínez-Negrete has been involved in various innovative healthcare projects and more recently on projects directly related to Covid-19 and, subsequently, to post-pandemic developments; while Lisandro Javier Herrera is a recognised expert in health regulation, governmental procurement processes, pharmaceutical regulation, molecular medicines, medical devices, digital health and compliance. At associate level,  the experienced Luis Marin Tijerina and younger colleague Martha Contreras advise clients on regulatory matters concerning pharma products, innovative and generic drugs, high-tech equipment, biotechnology, food supplements and medical devices, as well as clinical studies, cosmetics and personal hygiene products, and digital health, among other matters.

Practice head(s):

Bernardo Martínez-Negrete; Lisandro Herrera

Key clients

Mexican Health Foundation

Work highlights

  • Advice to FUNSALUD on the design and drafting of the digital health bill that has recently been submitted to the Federal Congress and is under discussion.

Hogan Lovells

International full-service firm Hogan Lovells has impressive life sciences credentials and expertise in industries including pharma, health care, consumer goods, chemicals, and technology. The practice group advises on matters including M&A transactions, the restructuring of business models and operations, labelling and advertising issues, the launch of new products, product liability, antitrust, and litigation, among others. Ernesto Algaba Reyes who focuses primarily on health law and regulatory compliance matters for the pharmaceutical and medical devices industries, is practice head. Specialist support is provided by counsel Cecilia Stahlhut Espinosa who has experience in regulatory drug matters, medical devices and equipment, research and development, biotechnology, compliance of new product technologies, and general health regulatory compliance. However, specialist associate Héctor Mercado moved to Cuesta Campos y Asociados S.C. in June 2022.

Practice head(s):

Ernesto Algaba Reyes

Testimonials

‘Constant communication between its internal teams to provide a comprehensive response.

‘Cecilia Stalhult extensive knowledge in regulatory matters.

 

Solórzano Linaldi

Solórzano Linaldi has a proven track record across the full spectrum of life sciences practice segments, with strong focus on pharmaceutical, healthcare and food and beverage industries. It advises clients on legal strategies to obtain marketing authorization for drugs in Mexico, regulatory framework issues – especially in relation to innovative projects, and represents clients in administrative and constitutional appeals, among other matters. The team is co-directed by name partners Guillermo Solórzano, who has led on many relevant cases regarding biotech products in the market, advises on strategies to obtain marketing authorisation for drugs and other products, and also undertakes litigation; and Luis López Linaldi, whose expertise is in the areas of international dispute settlement, technical barriers to trade, foreign investment, trade in services, and sanitary and phytosanitary measures. At associate level, senior Eréndira Frias, who has over 15 years’ experience and primarily advises national and multinational companies in pharmaceutical, sanitary, and administrative litigation; fellow senior  Christian Parra, an IP litigator; and associate Alan Osorio Aragón who advises on market analysis and health regulation with a focus on assisting clients introduce their products into the market, are the key figures.

Practice head(s):

Guillermo Solórzano Leiro; Luis López Linaldi

Testimonials

‘Luis López Linaldi is a very close partner to his clients, and has a genuine interest in their issues and business processes.

‘The knowledge capacity they have related to their topics, as well as the technology used in communication with the client, are outstanding.

‘Personalized and immediate attention.

‘The attention to contractual, regulatory and intellectual property aspects are agile. The follow-up of the partners is very close.

 

Key clients

International Maize and Wheat

Improvement Center

Hetero Labs

Pharmascience Inc

Apotex México

Glenmark Pharmaceuticals

Sun Pharma de México

Investigación Farmacéutica

Chemistry Linkage Unit of the Chemistry School of Universidad Nacional Autónoma de México

Beam Suntory

Casa Cuervo

Genbio

Vert Pharma

Gelpharma

Curology

Laboratorios Corne

CIPLA Pharmaceuticals

HB Fuller

Laboratorios Agroinsumos

Asesores en Calidad para Laboratorios

Work highlights

  • Advised Pharmascience on the legal analysis of the new scheme for the procurement of drugs implemented by the Mexican government with the assistance of the United Nations Office for Project Services (UNOPS).
  • Advised the Chemistry Linkage Unit on the design and implementation of a joint project with the Coalition for Epidemic Preparedness Innovations (CEPI), to provide lab-services focused on epidemics, including Covid-19.
  • Advised Laboratorios Corne on an administrative appeal against a decision issued by the Mexican Social Security Institute (IMSS) whereby such institute denied Corne its right to supply the drug Atazanavir under a contract already executed with the institute.

CMS Woodhouse Lorente Ludlow

CMS Woodhouse Lorente Ludlow has an established track record in life sciences and is highly experienced in administrative procedures, authorities’ audits and closures, cancellations of drugs, premarket approvals before Mexico's Food and Drug Agency (COFEPRIS), and strategies to launch new regulated products into the market, among other matters. The practice group - which advises international and local pharmaceutical companies, medical devices manufactures and chemicals companies, among others - is led by Mauricio Gómez Guerrero, a former public officer at COFEPRIS, who focuses on life sciences regulatory matters and has experience in regulatory enforcement administrative procedures, controlled substances and government affairs strategy. Associate Manuel Ferrara Ibarra plays a key role in the  implementation of legal defence strategies in both federal and local administrative procedures, as well as handling challenges related to administrative and fiscal matters and regulations.

Practice head(s):

Mauricio Gómez

Key clients

Boehringer Ingelheim

Essity Higiene y Salud México

Celanese Operations Mexico

Rubbermaid Commercial

Bioresearch de Mexico

Novag Infancia

Cyan Labs

Elevar Health

Randall Laboratories

GT Technologies

Work highlights

  • Advised Essity on applications for pre-market approval of medical-grade masks before COFEPRIS.
  • Advised Celanese Operations on the implementation of a quarterly audit program to ensure regulatory compliance in manufacturing and port facilities and in the design of a full regulatory compliance toolkit to ensure full traceability of the substances and a strong risk management system.
  • Advised Cyan Labs on all the administrative processes before the Mexican authority in order to obtain the Good Manufacturing Practices Certificate granted by Mexican Food and Drug Agency, COFEPRIS.

Creel, García-Cuéllar, Aiza y Enríquez, S.C.

Creel, García-Cuéllar, Aiza y Enríquez, S.C.‘s life sciences practice is focused on providing regulatory and transactional advice in the pharma, medical device, biotechnology, and food and beverage industries on matters such as compliance with sanitary regulations, labelling requirements, and registrations and authorisations, as well as transactional advice and litigation. The team – which is well regarded for ‘knowing the various complex laws around life sciences exceedingly well and applies it in a practical way’ – is co-led by insurance and regulatory specialist Leonel Pereznieto and Iker Arriola, whose input is in terms of corporate, finance, transactional and competition matters . Also, a key player in the practice, specialist counsel Guillermo Govela -whose past experience includes time at both COFEPRIS and the office of the Health Secretary- has a close focus on health regulation and administrative law; clients identify him as ‘smart, timely and extremely responsive on a range of time-sensitive needs’. Since research concluded, the team has been further bolstered with the September-2022 hire of experienced senior associate David Campos, who has considerable litigation experience in relation to life science matters, from Baker McKenzie Abogados, S.C..

Practice head(s):

Leonel Pereznieto; Iker Arriola

Testimonials

‘Complete service in one place. Few law firms in Mexico have the capacity to deal with all kinds of issues “in the same place”.

‘Unmatched commitment and response times.

‘The team knows the various complex law around life sciences exceedingly well and applies it in a practical way that we appreciate and respect. We often bring on the Creel team as co-counsel for matters on behalf of our multinational clients with Mexican business interests.

‘Guillermo Govela Martínez is smart, timely and extremely responsive on a range of time-sensitive needs. He’s been instrumental in a range of high stakes life sciences matters.

‘The team demonstrated expertise in challenging digital health matters. Besides, they are very responsive and willing to provide helpful assistance.

‘I had the opportunity to work with Leonel Pereznieto and Guillermo Martínez in a multi-jurisdictional digital health project. Deliverables and responsiveness were excellent!

Key clients

Inovio Pharmaceuticals

Bristol-Myers Squibb de México

Genomma Lab Internacional

Thor Químicos de México

Meade Johnson Nutricionales de México

Covington and Burling,

PayPal

Monster Beverage Corporation

Amgen México

Columbus McKinnon de México

Work highlights

  • Successfully advised US-based biotechnology company Inovio ion its request for authorisation from COFEPRIS to conduct a Phase 2/3 clinical trial in Mexico for its DNA vaccine candidate for Covid-19, INO-4800.
  • Advised Abbott Nutrition as to the applicable legal framework for infant formulas in Mexico, including specific considerations regarding ingredients, additives, and the naming of such ingredients and additives, as well as the applicable regulation to the fortification of infant formulas.
  • Advised Genomma Lab International regarding sanitary advertising requirements for cosmetic products, medical devices, and dietary supplements, for preventive purposes, as well as to use this evaluation in a Consumer Protection administrative procedure.

Ibarra, del Paso y Gallego

Extremely professional‘, Ibarra, del Paso y Gallego has an excellent reputation in life science and is well regarded for having ‘an ‘excellent disposition and remarkable approach to the client.’ The practice has experience in regulatory and sanitary consulting and litigation, and health and sanitary regulation matters, and provides legal advisory on a wide range of areas including research and development, pharmaceuticals, industrial and biotechnological products, medical devices, chemicals, agrochemicals, tobacco, and food and beverages. The team is co-led by Adrián del Paso Puente, who provides legal advice to a wide range of companies in the regulated industries, along with not-for-profit organisations, related to the health sector in Mexico; he is also an experienced litigator, particularly on administrative and regulatory matters. Fellow practice co-lead, Juan Manuel Alvarez del Castillo, who is also head of the intellectual property practice, oversees the IP aspects of life science matters related to the pharmaceutical, chemical, technological, and food and beverage industries. Specialist associate Ricardo Koller left the firm in late 2022.

Practice head(s):

Adrián del Paso; Juan Manuel Álvarez del Castillo

Testimonials

‘The team is extremely professional, with excellent disposition and remarkable approach to the client. The personalised service they have stands out and they are always looking for new ways to work in the field for the benefit of customer and industry.

‘The lawyers know the needs of their clients and know how to provide personalized services, they are responsible, prompt and with an excellent approach to service that stands out. Adrian del Paso is excelent.

Key clients

The Chemours Company

Hilton Grand Vacations Inc

Work highlights

  • Advised on the Mexican portion of a multinational M&A transaction entailing the sale of Chemours’ Mining Solutions Business to Draslovka Holding company, which specializes in chemicals; the life sciences team coordinated and led the efforts on the mapping and strategy design related to the health-related permits required for the transferrals to the newly created company.  
  • Advised Hilton Grand Vacations on the Mexican aspects of a multinational M&A transaction involving the acquisition of USA’s timeshare company Diamond Resorts; the life sciences team undertook a thorough due diligence review, including review of target’s compliance with Covid-19 related sanitary guidelines.

Basham, Ringe y Correa, S.C.

Basham, Ringe y Correa, S.C.'s life sciences practice advises clients primarily drawn from the healthcare, tobacco, cannabis, chemicals, and food and beverage industries on regulatory and litigious matters relating to manufacturing, importation, distribution, marketing, labelling and advertising. The practice is comprised by specialised lawyers and technical personnel including chemists and biologists, and works in coordination with other areas at the firm - most notably intellectual property, data protection and compliance. Following the May 2022 retirement of Daniel Del Rio , the practice is now solely directed by Rodolfo Barreda, who has represented several pharmaceutical companies in administrative procedures before sanitary authorities, as well as in constitutional procedures. Key support comes from Ricardo Evangelista, associate director of the environmental, national waters and climate change practice at the firm, who has over 10 years' specialising in regulatory compliance matters.

Practice head(s):

Rodolfo Barreda

Testimonials

‘Basham is a law firm always open to seeking innovative solutions and alternatives from a legal point of view to support the company’s objectives.

‘The firm’s lawyers have extensive experience and knowledge in the matters they work on, as well as a support network within the firm to complete aspects that may go unnoticed. On the other hand, the team has a sense of urgency and availability that allows them to respond to the needs of companies.

Key clients

Alexion Pharmaceuticals

Alfa Wasserman

Aspid

Coca Cola

KT&G

Zimmer Biomet

Align

Bayer

Benefit Cosmetics

Sephora

Clorox

Canopy Growth Corporation

Immunotec

Morinda

Cochlear

Elixinol

Vestaron

Moet Hennessy

Louis Vuitton

Lifescan

Olympus

BASF

PTS Diagnostics

Altria Ventures

Envasadora D’Aqua

International Grains and Cereal

Natural One

González Calvillo, SC

González Calvillo fields a team with experience in regulatory compliance for the import, marketing, distribution, storage, advertising, and sale of products such as drugs, medical devices, food supplements, food and beverages, spirits, and tobacco products. Following the sad and premature passing of former environmental head Leopoldo Burguette-Stanek in March 2022, the practice is now co-led by counsels Enrique Muñoz Guízar, who advises companies on identifying and obtaining the permits, licenses, authorisations, and concessions that they may require for their activities and operations; and Carlos Fernando Castilla, who focuses his practice on administrative litigation and dispute resolution, and has experience designing complex defence strategies.

Practice head(s):

Enrique Muñoz Guízar; Carlos Fernando Castilla

Key clients

Amazon

Aquafarms

Axalta

Danone

DuPont

Dosal Tobacco

Eagle Foods

Eucalyptus Medical

Future Health Biobank

Google

Jafra Cosmetics

Kabisa Energy Drink

Little Caesar’s

M3 Resources

Mezcal Cinco 70

Mezcal El Silencio

Omron

Philip Morris

Pioneer

Red Bull

Regal Springs Mexico

Sánchez Devanny

Sánchez Devanny routinely assists clients in the pharma, chemical, cosmetics, tobacco, and food and beverage industries on a range of life science matters including regulatory, compliance, approvals, marketing, labelling and litigation. The practice is co-directed by José Alberto Campos-Vargas, who handles regulatory matters, international trade and administrative litigation; and Juan Luis Serrano, who has experience in government procurement and crossover IP matters. In addition, the pair can call on the expertise of senior associate Maria Luisa Mendoza López who handles international trade and has a particular focus on the import and export requirements for regulated products which correspond to the life sciences industry.

Practice head(s):

José Alberto Campos-Vargas; Juan Luis Serrano

Testimonials

‘It is a large firm that can advise companies in all aspects, from corporate, to intellectual property, labor to regulatory and tax.

‘Partner Juan Luis Serrano’s experience as an in-house attorney makes his practice unique, since he knows very well the needs and pressures that exist as an in-house attorney and he knows his practice as an external advisor very well. That is reflected not only in the work but in the quotes.

‘The life science team of Alberto Campos is a team that is in permanent contact with us as clients using technological means, there is a very cordial and close communication.

‘What differentiates the lawyers of Sanchez Devanny’s life sciences practice is their deep technical knowledge of the norms of sanitary regulation.

 

Key clients

Femsa-KOF

Schwan Stabilo

Procter & Gamble

L’Oreal

UCB Pharmaceuticals

British American Tobacco

Yanbal

Grupo Embotellador Pepsico

Slimfast

Merck

Work highlights

  • Advised Teva Pharmaceutical Company on several regulatory scenarios surrounding the re-launch of their portfolio in Mexico.
  • Advised a tobacco company in connection with the legal regime applicable to vaping products, starting from the customs classification of the vapes and cartridges for the vapes, tariff and non-tariff restrictions and the regulations, permits and authorisations necessary for their importation into Mexico and further marketing thereafter.
  • Advised Procter and Gamble on several regulatory scenarios related to the acquisition of Merck’s consumer health division, including available pathways before the authority.

Santamarina y Steta

Santamarina y Steta combines transactional and regulatory experience to provide a strong offering in life science matters to companies in the food and beverage, chemicals, pharma, healthcare and tobacco industries, handling the verification of  compliance with applicable Mexican laws, regulations and standards – primarily in relation to the manufacture and distribution of products. The practice is led by Alejandro Luna, who has experience advising national and international clients on foreign trade and customs, health and life sciences, and consumer protection. Key support is provided by associate Mariana Larrea who focuses on the life science and healthcare areas, particularly regarding the analysis, research and advertisement of products and services.

Practice head(s):

Alejandro Luna

Testimonials

‘Specialists in the area of healthcare and regulatory issues.

‘Good follow-up, expert advice on the subject, the lawyers who assisted us were Mariana Larrea and Alejandro Luna.

‘They were quick in their attention and very professional. The answers they provided were well substantiated.

Key clients

Agilent Technologies Mexico

Kimberly Clark de México

Grupo Industrial Monclova

DXN Holdings

Upjohn Pharma Mexico

Driscoll’s

Innophos Fosfatados de México

Martinrea Developments de México

Cosmocel

BioMarin Pharmaceutical

Christus Muguerza Servicios Hospitalarios

Hellman & Friedman

MGP Ingredients

Work highlights

  • Advised Agilent, a service-solutions provider for the pharmaceutical industry, on matters regarding the importation of lab tests and other regulatory sanitary matters, including sanitary registrations.
  • Advised  Kimberly-Clark on regulatory matters regarding cleaning and personal care hygiene products, as well on advertising, labelling and in a recall order issued by the FDA.