Life sciences in Mexico

Baker McKenzie Abogados, S.C.

Established as the firm of choice for several major pharmaceutical, laboratory and cosmetics companies, Baker McKenzie Abogados, S.C. has impressive expertise in the life sciences and healthcare industries. The firm houses a sizable practice headed by partner Christian Lopez-Silva, a recognised expert in the healthcare and biotechnology segments. Under his guidance, the team focuses on regulatory matters, dispute resolution, privacy and data security, as well as associated foreign trade issues. Key support and essential additional expertise are brought in by partner José Hoyos and senior associate David Campos. The team also includes a pharmaceutical chemist among its ranks.

Practice head(s):

Christian Lopez-Silva

Key clients

FedEx

Hershey

Troy Chemicals

Estee Lauder

Takeda

Laboratorios Ferrer

Biogen

Alcon

Merck Animal Health

Baxter

Becton Dickinson

Boston Scientific

Biomarin

Bristol Myers Squibb

Novo Nordisk

Ortho Clinical Diagnostics

Pfizer

Medtronic

Stryker

Novartis

Work highlights

  • As a pro bono project, assisted the Medical Centre ABC to defend against an action from COFEPRIS (the local health regulator).
  • Assisted a large number of non-healthcare clients with manufacturing operations in the country, affected by health-related decrees.
  • On behalf of Takeda, prepared an urgent analysis regarding a recent ministerial decree that introduced an equivalency route for products with prior approvals from 59 countries.

Galicia Abogados S.C.

One of the most specialised firms in the pharmaceutical industry’, Galicia Abogados S.C. houses a highly experienced, eight-strong life sciences practice. The department is fronted by two exceptional practitioners: Bernardo Martínez-Negrete, who focuses on all aspects of the pharmaceutical industry, from M&A to clinical trials; and Lisandro Javier Herrera, appointed counsel in January 2021, who has a solid background as regional director at generics company Teva, which he puts to use in his broad life sciences practice. The department is a regular advisor to key players in the pharmaceutical industry, which it assists in regulatory, compliance and day-to-day matters. Corporate matters and transactions, as well as dispute resolution also feature in the department's workload. Luis Marin Tijerina is a name to note at the associate level.

Practice head(s):

Bernardo Martínez-Negrete; Lisandro Javier Herrera

Testimonials

‘The firm has a highly experienced Life Sciences practice and is one of the most specialised firms in the pharmaceutical industry’

‘They are very knowledgeable and trustworthy. They show honest concern and support for their clients’

‘They welcome feedback in a very open manner. They have a remarkable insight into international law. Their interaction with global law firms and associations gives them a very broad view’

‘Lisandro Herrera shows a great willingness to collaborate. He cares about understanding the client’s needs to the full. He keeps himself permanently updated’

Key clients

Mexican Health Foundation (FUNSALUD)

Carestream Dental de México

Work highlights

  • Advised Mexican Health Foundation (FUNSALUD) on the implementation of digital health technology initiatives in Mexico, such as the use of drones, e-health, m-health, access to information, robots and Internet of Things (IoT) related to health matters.
  • Advises Carestream Dental de México, a provider of digital imaging, software and practice management solutions for dental practitioners, on regulatory matters regarding medical devices.

Hogan Lovells

Highly regarded full-service firm Hogan Lovells fields a ‘very well-integrated team with specialists in various branches of life sciences’. The department is well versed across a broad range of matters in the sector, from Official Mexican Standards (NOMs), consumer protection, product liability and sanitary registrations, to overland transport, foreign trade, contracts and patents. The five-strong practice also boasts relevant capabilities in handling sensitive compliance matters, and the planning and implementation of strategies for the restructuring of business operations. The team comprises an ‘exceptional’ duo of practice head Ernesto Algaba Reyes, who stands out for his expertise in the pharmaceutical and medical devices industries, and counsel Cecilia Stahlhut, who has particular knowledge of the regulation of cosmetics, food, alcohol, tobacco and consumer products.

Practice head(s):

Ernesto Algaba Reyes

Testimonials

‘They are a robust team with extensive knowledge and coordination between them, especially Omar Guerrero, Arturo Tiburcio and Cecilia Stalhult’

‘A very well-integrated team with specialists in various branches of life sciences, including food, beverages, medical devices and pharmaceuticals. Cecilia Stahlhut’s previous experience in foreign trade issues offers an additional advantage regarding imports and exports of regulated products’

‘Ernesto Algaba and Cecilia Stahlhut are exceptional. They understand the complexities of the Mexican regulatory authorities very well and keep up to date with the latest developments in the field’

‘Cecilia Stahlhut and Ernesto Algaba: great availability, knowledge and creativity in providing solutions’

Key clients

Gilead Sciences

CSL Behring

Bristol-Myers Squibb

ConAgra

Procter & Gamble

J.R. Simplot Company

Ocean Spray

Lamb Weston

Rich Products

Amazon

Roche

Work highlights

  • Providing public procurement and health regulatory advice to Gilead Sciences concerning its operations in Mexico.
  • Provided CSL Behring full regulatory advice in connection with the company’s business model and activities.
  • Acts as advisor to Procter & Gamble on health regulatory for ensuring proper compliance for its new business relating to drugs and dietary supplements.

CMS Woodhouse Lorente Ludlow

Highlighted for its 'excellent results', the five-strong life sciences practice at CMS Woodhouse Lorente Ludlow is well known for its track record in representing clients before health-related governmental agencies. Its clients often seek the department's assistance in new businesses and products, regulatory strategies and compliance audits, good manufacturing practices and certifications, premarket approval of products and services, health licenses and advice on labelling and marketing of regulated products and services. Practice head Mauricio Gómez regularly advises on life sciences regulatory matters, pharmaceutical products, biotech and medical devices, among several other areas, and also benefits from his previous experience in different posts at regulator COFEPRIS. Other key practitioners include corporate law expert César Lechuga and PPP specialist Marcia Santomé.

Practice head(s):

Mauricio Gómez

Testimonials

‘They offer great service in health issues, always with excellent results.’

‘They have great knowledge of national and international regulations. It is one of the few law firms in Mexico that has this branch of specialities’

Key clients

Celanese Celanese Corporation

Essity Higiene y Salud

Gresmex

GC77 Quimisumistros en México

Work highlights

  • Advising Celanese on day-to-day regulatory matters and risk assessments of relevant operations, because its chemicals are controlled substances according to COFEPRIS.
  • Advising Essity Higiene y Salud on the regulatory portfolio of pre-market approval for tampons and menstrual cups.
  • Advised Gresmex on the regulatory strategy to work with outside manufacturers while building the new plant, and in the certifications and authorisation of the new facility.

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

Knowledgeable regulatory experts with a strong business sense’ is how one client describes the eight-strong life sciences practice at Creel, García-Cuéllar, Aiza y Enríquez, S.C. The firm has a solid track record advising multinational companies on the regulatory aspects related to health regulation in Mexico for their corporate transactions. Begoña Cancino, who is also the head of IP, leads the department, which boasts notable expertise in data privacy, regulatory matters and administrative litigation. The latest additions to the team have also made their mark recently: counsel Guillermo Govela, a health regulation and administrative law specialist who has former experience at the Ministry of Health and at pharmaceutical products company Nadro; and mid-level associate Lizbeth Borquez. Also of note is the team's ability to draw on the firm's full-service capabilities to offer complete coverage of life sciences matters, covering the transactional, unfair competition, corporate, regulatory, disputes, IP and trade perspectives.

Practice head(s):

Begoña Cancino

Testimonials

‘They manage to harmonize the various legal and regulatory provisions that exist in a myriad of regulations on various subjects, making a comprehensive analysis that ensures consistency in the interpretation and implementation of legal recommendations’

‘Knowledgeable regulatory experts with a strong business sense’

‘They are a multidisciplinary team with expertise in all matters related to life sciences’

Key clients

Monster Beverage Corporation

Freshfields Bruckhaus Deringer LLP

Covington and Burling LLP / DC Office

Wilmer Hale, LLP

Colgate Palmolive

Bristol-Myers Squibb de México

Quiroga Advogados

FIFCO México

Covington and Burling LLP / LA Office

Evonik Industries de México

Work highlights

  • Provides legal and regulatory advice to a large multinational company on compliance with the new labelling and nutritional information requirements set forth by the modification of Mexican Official Standard NOM-051.
  • Provided advice and regulatory background on cannabis regulation in Mexico to a client.
  • Acts as Mexican counsel for an international pharmaceutical company on the Mexican legal regulatory framework regarding opioid regulation and liability.

González Calvillo, SC

The life sciences team at González Calvillo, SC is praised by clients for making them ‘feel very safe’, and for offering a ‘world-class service’. The department is regularly called upon by major players from the pharmaceutical, food and beverage and technology industries. Renowned environmental specialist Leopoldo Burguete-Stanekknows his area of expertise perfectly’; he jointly leads the practice with counsel Enrique Muñoz Guízar, an expert in environment, life sciences, healthcare and consumer protection, who has ‘a deep knowledge of industry regulation’. Fellow counsel Carlos Castilla and senior associate Georgina Zavala are also key members of the team.

Practice head(s):

Leopoldo Burguete-Stanek; Enrique Muñoz Guízar

Testimonials

‘It is very easy to work with them, they handle the area very well and are always available’

‘Leopoldo Burguete knows his area of expertise perfectly, so he always guides and advises us very well. We feel very safe working with them’

‘They advise us on everything from health law and handling of personal data, to labour law and drafting agreements with allies. They are very quick to respond to our legal requirements and questions’

‘The value for money is very good. I feel we get a world-class service at a very affordable price’

‘They proactively alert me to changes or potential changes in health regulation’

‘The practice heads are specialists in health law’

‘The explanations are always clear and there is transparency in communication’

‘Leopoldo Burguete has such good interpersonal skills that he makes you feel like a friend after five minutes. Enrique Muñoz, in turn, is clear and accessible, and has a deep knowledge of industry regulation’

Key clients

Dow

DuPont México

Philip Morris

Amazon

Prestige Brands

Axalta

Immunotec

M3 Resources

Danone

Jafra Cosmetics

Google

Omron

Little Caesars

Dosal Tobacco

Pioneer (Du Pont Seeds)

Red Bull

Eucalyptus Medical

Kabisa Energy Drink (Mexico)

Future Health Biobank

Mezcal El Silencio

Mezcal Cinco 70

Backbar Project (Tepachería El Sazón)

Sanalcom

M3 Resources

Ibarra, del Paso y Gallego

Ibarra, del Paso y Gallego ‘keeps growing enormously in the speciality of life sciences’, offering clients transactional and regulatory legal advice, life sciences-focused due diligence support, and providing technical and legal support in obtaining health care, biotechnology and other related authorisations. Another key service provided by the firm is legal representation before the Ministry of Health, the Federal Commission for the Protection against Health Risks (COFEPRIS), and other relevant authorities. Jointly headed by Adrián del Paso, who is well known for his environmental expertise but is increasingly active in the life sciences sector; and Juan Manuel Alvarez del Castillo, the team's recent work highlights have included the review of numerous complex contracts related to the commercialisation and distribution of foreign third-party pharmaceutical products.

Practice head(s):

Adrián del Paso; Juan Manuel Álvarez del Castillo

Testimonials

‘This firm keeps growing enormously in the speciality of life sciences. Their concern to provide the best service, made them specialize and grow in terms of knowledge in this area’

‘The firm is involved in all events related to the subject, which has made them experts in the field and always up to date with the latest developments’

‘They are interactive and thorough in discussing potential legal issues with their clients, which helps in assessing and prioritizing what issues should be addressed first’

‘Ibarra’s billings are clear’

‘They have technology resources that support face-to-face discussions, which is particularly beneficial when the client is in the US, and the issue and the firm is in Mexico. We know that we can easily reach Ibarra attorneys as needed’

Solórzano Linaldi

Although a recent entry to the Mexican market, Solórzano Linaldi is a spin-off from Solcargo, having launched itself in the life sciences arena while retaining its key team, clients and mandates. The team is led jointly by Guillermo Solórzano Leiro, whose broad practice includes life sciences, regulatory and pharmaceutical issues, as well as associated patent and trade mark litigation and administrative litigation; and Luis López Linaldi, a specialist in pharmaceutical trade, IP and regulatory matters. The department is well versed across a broad range of areas, from regulation to litigation, and acts for a diverse portfolio of clients operating in the pharmaceutical, biotechnology, and food and beverage sectors, among others. The firm also benefits from the input of several talented senior associates, including Eréndira Frías, who specialises in administrative litigation, and Christian Parra, an expert in IP litigation and unfair competition.

Practice head(s):

Guillermo Solórzano Leiro; Luis López Linaldi

Key clients

International Maize and Wheat Improvement Center

Hetero Labs

Agilent Technologies

Apotex México

Glenmark Pharmaceuticals

Sun Pharma de México

Investigación Farmacéutica (IFA CELTICS)

Compañía Casa Dragones

Beam Suntory

Casa Cuervo

Genbio

Vert Pharma

Gelpharma

Curology

SBL Pharmaceuticals

CIPLA Pharmaceuticals

H.B. Fuller

Laboratorios Agroinsumos

Clínica del Manejo de la Edad

Work highlights

  • Assisted H.B. Fuller with the design of a legal strategy regarding the importation, warehousing and distribution of advanced disinfectants which had already demonstrated effectiveness against viruses similar to Covid-19 virus.
  • Assisted AMELAF in connection with a constitutional controversy filed by the Mexican Senate to challenge the amendments made to Article 1 of the Mexican Law for Procurement, Leasing and Acquisition of Services for the Public Sector.
  • Advising Gelpharma on addressing several challenges of bidding procedures, in which it was awarded the supply of drugs with Vitamin E and alendronate sodium.

Basham, Ringe y Correa, S.C.

Basham, Ringe y Correa, S.C. combines expertise in both regulation and litigation, with broad knowledge of the manufacturing, marketing, labelling and advertising of pharmaceutical products, medical devices, pesticides, fertilisers, cosmetics, and myriad other products, where it acts for household name brands and companies. The practice includes noted practitioners such as corporate expert Daniel Del Rio, who maintains a broad practice, with a particular focus on the healthcare sector; public law specialist Rodolfo Barreda; and associate Ricardo Evangelista.

Practice head(s):

Daniel Del Rio; Rodolfo Barreda

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

Work highlights

  • Advised Cochlear regarding the incorporation of a local subsidiary for the import and distribution of cochlear implants in Mexico.
  • Advised Mattel de México regarding the possibility of manufacturing face masks for donation without any authorisation required from Federal Commission for the Protection Against Sanitary Risks.
  • Acts as advisor to Canopy Growth Corporation for the implementation of its regulatory operations in the country.

DLA Piper Gallastegui y Lozano

The life sciences practice at DLA Piper Gallastegui y Lozano assists clients with obtaining licenses and authorisations, including regulatory approvals, from the relevant authorities. It remains particularly active representing clients in constitutional amparo appeals against administrative authorisations. Other areas keeping the team busy include clinical trial matters, regulatory advisory on imports, and transactional operations. Key contacts in the team include: corporate law expert Jorge Benejam, who has a strong focus on highly regulated sectors; Eduardo Gallastegui, one of the lawyers who participated in the Federal Health Law reform; and corporate and transactional partner Xavier Mangino Dueñas.

Practice head(s):

Eduardo Gallastegui; Jorge Benejam

Santamarina y Steta

Highly regarded for its ‘specific knowledge of the functioning of regulatory authorities’, Santamarina y Steta's life sciences practice is a popular choice for clients from the pharmaceutical, medical devices, cosmetic, seed, fertiliser, plant nutrients and food industries, for its expertise on compliance with applicable Mexican law, regulations and standards. Administrative litigation, corporate transactions and international trade and commerce matters related to the life sciences sector also feature in the department's workload. Boasting significant skills assisting companies with compliance and regulatory advice, Alejandro Luna leads the department, closely supported by mid-level associate Mariana Larrea.

Practice head(s):

Alejandro Luna

Testimonials

‘They have specific knowledge of the functioning of regulatory authorities’

‘They have the advantage of not only having highly qualified and experienced lawyers in this sector, but they also form interdisciplinary teams that produce synergy’

‘Mariana Larrea and Alejandro Luna form a very good team where each one’s skills are leveraged to achieve a favourable result. They are all very responsible and committed‘

Key clients

Hershey México

Kimberly Clark de México

Grupo Industrial Monclova

NEB

Upjohn Pharma Mexico

Driscoll’s

Paypal México

Martinrea Developments de México

Work highlights

  • Provided regulatory advice to Hershey México on obtaining several Free Sale Certificates, Operation Notices, Certificate of Conformity of Good Health Practices, Certificate for Export of Conformity of Good Sanitary Practices and Advertising Notices, before COFEPRIS.
  • Provided legal and regulatory assistance to Kimberly Clark de México regarding its cleaning and personal care hygiene products.
  • Advised GIMSA regarding the creation and implementation of a regulatory strategy for a new JV company.

Sánchez Devanny

The sizable life sciences team at Sánchez Devanny counts a number of household name companies among its clients. The firm maintains a broad offering, and particularly stands out for its contentious capabilities. Areas of expertise include pharmaceuticals, medical devices, food and beverages, dietary supplements, cosmetics, tobacco, hazardous substances, cannabis products, and medical and health-related services. The department is jointly led by José Alberto Campos and Juan Luis Serrano-Leets, who advises life sciences clients on IP, regulatory and privacy matters, and has former experience as the head of legal at AstraZeneca Mexico. Non-equity partner María Luisa Mendoza is another name to note.

Practice head(s):

José Alberto Campos; Juan Luis Serrano-Leets

Testimonials

‘The team has excellent knowledge of the labeling requirements for food and beverage products, as well as of underlying regulations applicable’

‘Maria Luisa Mendoza has been very responsive on numerous occasions when we have faced issues of critical timing and risk exposure’

‘Juan Luis Serrano has extensive experience in regulatory and intellectual property issues for the chemical and pharmaceutical areas, where he also has experience as an in-house lawyer for a big pharma company’

‘Juan Luis Serrano shows his vast knowledge of the subject in a simple and down-to-earth way to any audience’

Key clients

FEMSA-KOF

Schwan Stabilo

Procter & Gamble

L’Oréal

UCB Pharmaceuticals

British American Tobacco

Yanbal

Mary Kay Cosmetics

Slimfast

Merck

Work highlights

  • Advised a large multinational cosmetics company on several regulatory requirements surrounding a change of physical address.
  • Advised Exeltis Pharma on the development and launch of its telemedicine platform – a first of its kind in Mexico.
  • Represented British American Tobacco in litigation regarding the prohibition by the Mexican Health Authorities to import and market vaping products.