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Medicines: technical services
Regulatory

Medicines: technical services

Master the regulations to successfully market your products in each market. Knowing the regulatory framework is key to the success and permanence of your product.

What we do for you

  • Preliminary advice
    • We define the regulatory framework of your project from the beginning to ensure regulatory compliance.
  • Regulatory strategy and roadmap
    • We mark regulatory milestones in the development stages (from regulatory pre-clinical to clinical).
  • Quality system
    • Compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) throughout the life cycle.
  • Preclinical and clinical development
    • Technical support in preclinical and clinical development in relation to all regulatory requirements in the different jurisdictions.
  • Marketing authorization application
    • We carry out the GAP analysis, the preparation of the registration dossier (CTD), as well as the submission and follow-up with the regulatory authorities.
  • Post-marketing support
    • Management of any updates after product release.

Everything you need, in one place

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Optimization of product development through regulatory strategy.
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Tailored for each type of medicinal product and Legal Basis.
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Team with experience in innovative developments, including Biologics and ATMP
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Expertise in approval and commercialization in international markets, with presence in Latin America and emerging markets.

News

Explore our latest news, articles, and events to stay up to date on the trends that move the world of innovation.

WHO Recognition of ANVISA as a Listed Authority for Medical Devices: What It Means for Market Access in Brazil
The World Health Organization (WHO) has taken an important step toward strengthening global regulatory convergence in the medical device sector. In July 2026, WHO published its transitional list of WHO Listed Authorities for Medical Devices (tWLAs-MD), recognizing only 12 national regulatory authorities and regional regulatory systems worldwide for their demonstrated regulatory oversight capacity. Brazil’s National […]
Articles
Brazil’s Regulatory Transformation: Why Global Life Sciences Companies Should Enter the Brazilian Market Now
Brazil, the largest pharmaceutical market in Latin America, has just removed one of the biggest barriers to entry. Since June 29, 2026, pharmaceutical companies no longer need to have their products registered in another country before applying for registration with ANVISA, the Brazilian health regulatory agency. Combined with a strengthened regulatory reliance framework, this unprecedented […]
Legislative news
Brazil’s Cosmetics Regulatory Transformation: Stronger Ingredient Controls and a New Era of Cosmetovigilance
Brazil’s cosmetics and personal care sector is entering a new phase of regulatory maturity. In the past two years, Anvisa has introduced a series of measures that strengthen oversight across the entire product lifecycle—from ingredient selection and formulation compliance to post-market safety monitoring. Together, these initiatives demonstrate a clear regulatory objective: enhancing consumer protection through […]
Legislative news
WHO Recognition of ANVISA as a Listed Authority for Medical Devices: What It Means for Market Access in Brazil
The World Health Organization (WHO) has taken an important step toward strengthening global regulatory convergence in the medical device sector. In July 2026, WHO published its transitional list of WHO Listed Authorities for Medical Devices (tWLAs-MD), recognizing only 12 national regulatory authorities and regional regulatory systems worldwide for their demonstrated regulatory oversight capacity. Brazil’s National […]
Articles
Brazil’s Regulatory Transformation: Why Global Life Sciences Companies Should Enter the Brazilian Market Now
Brazil, the largest pharmaceutical market in Latin America, has just removed one of the biggest barriers to entry. Since June 29, 2026, pharmaceutical companies no longer need to have their products registered in another country before applying for registration with ANVISA, the Brazilian health regulatory agency. Combined with a strengthened regulatory reliance framework, this unprecedented […]
Legislative news
Brazil’s Cosmetics Regulatory Transformation: Stronger Ingredient Controls and a New Era of Cosmetovigilance
Brazil’s cosmetics and personal care sector is entering a new phase of regulatory maturity. In the past two years, Anvisa has introduced a series of measures that strengthen oversight across the entire product lifecycle—from ingredient selection and formulation compliance to post-market safety monitoring. Together, these initiatives demonstrate a clear regulatory objective: enhancing consumer protection through […]
Legislative news
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Meet the drug team: technical services

Find the right expert to offer you customized solutions.

Clara Pombo
Clara Pombo Group Chief Regulatory Services Officer

ClarkeModet
Fernanda Manhães
Fernanda Manhães Regulatory Services Director

ClarkeModet Brasil
Mª José Reyes
Mª José Reyes Regulatory Services Director

ClarkeModet España
Cruz Naval
Cruz Naval Regulatory Services Director

ClarkeModet España
Ana Cristina García
Ana Cristina García Country Managing Director Paraguay

ClarkeModet Paraguay
Maria Celeste Pinto
Maria Celeste Pinto Country Managing Director Venezuela

ClarkeModet Venezuela
Fabiana Penadés
Fabiana Penadés Country Managing Director Uruguay

ClarkeModet Uruguay
Conchi Torrejón
Conchi Torrejón Senior Regulatory Consultant

ClarkeModet España
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Contact our experts

Innovation starts with a conversation and a question: how can we help you? Contact the right expert for your needs. We are here to help.

Claudia Marquez IP Senior Consultant

ClarkeModet México
Victor Fachim IP Senior Consultant

ClarkeModet Brasil
Matheus Aguiar IP Senior Consultant

ClarkeModet Brasil
José Ayala IP Senior Consultant

ClarkeModet Chile
Carlos Tapia Country Managing Director Dominicana

ClarkeModet República Dominicana
Pedro Lages IP Senior Consultant

ClarkeModet Portugal
Maite Sales Regulatory Business Development

ClarkeModet
Martín Roca International IP Senior Consultant

ClarkeModet Brasil
Leo Qi International IP Consultant

ClarkeModet España