Web Analytics
Contact us
icon
Buscar en Clarke Modet
Contact us
Home
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

Size=XL, Color=Azul, Icono=Entorno, Variante = 12

Optimization of product development through regulatory strategy.
icons-4

Tailored for each type of medicinal product and Legal Basis.
icons-6

Team with experience in innovative developments, including Biologics and ATMP
Size=XL, Color=Azul, Icono=Interfaz, Variante=03

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.

ClarkeModet strengthens its Regulatory Services in Brazil with the appointment of Fernanda Manhães
ClarkeModet has appointed Fernanda Manhães as its new Regulatory Services Director in Brazil, strengthening its ability to support healthcare companies in an environment marked by increasing regulatory demands and ever more critical timelines for market entry and continued presence in the Brazilian market. With more than 15 years of international experience in Regulatory Affairs, Fernanda […]
Articles
ClarkeModet promotes its internal talent with the appointments of Dina Chaves and Luisa Castro
At ClarkeModet, we are pleased to announce two strategic appointments that reinforce our commitment to developing internal talent. Dina Chaves, until now Group Consultacy Officer, has been appointed Group Chief International Business Officer. Meanwhile, Luisa Castro, who previously led the Patents and Translations area, has been appointed Group Chief Operations and Quality Officer. Dina Chaves […]
Articles
Spain Updates its Regulations on In Vitro Diagnostic Medical Devices to Align Fully with EU Requirements
On 21 October 2025, Spain approved Decree 942/2025, which updates the national framework for in vitro diagnostic medical devices and aligns it with Regulation (EU) 2017/746 (IVDR). This new decree replaces Decree 1662/2000, in force since 2000. The reform strengthens safety, quality, and transparency in the diagnostic sector, while supporting innovation, competitiveness, and trust among […]
Legislative news
ClarkeModet strengthens its Regulatory Services in Brazil with the appointment of Fernanda Manhães
ClarkeModet has appointed Fernanda Manhães as its new Regulatory Services Director in Brazil, strengthening its ability to support healthcare companies in an environment marked by increasing regulatory demands and ever more critical timelines for market entry and continued presence in the Brazilian market. With more than 15 years of international experience in Regulatory Affairs, Fernanda […]
Articles
ClarkeModet promotes its internal talent with the appointments of Dina Chaves and Luisa Castro
At ClarkeModet, we are pleased to announce two strategic appointments that reinforce our commitment to developing internal talent. Dina Chaves, until now Group Consultacy Officer, has been appointed Group Chief International Business Officer. Meanwhile, Luisa Castro, who previously led the Patents and Translations area, has been appointed Group Chief Operations and Quality Officer. Dina Chaves […]
Articles
Spain Updates its Regulations on In Vitro Diagnostic Medical Devices to Align Fully with EU Requirements
On 21 October 2025, Spain approved Decree 942/2025, which updates the national framework for in vitro diagnostic medical devices and aligns it with Regulation (EU) 2017/746 (IVDR). This new decree replaces Decree 1662/2000, in force since 2000. The reform strengthens safety, quality, and transparency in the diagnostic sector, while supporting innovation, competitiveness, and trust among […]
Legislative news
Go to news
equipo-movil (3)

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
final-img

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 International IP Consultant

ClarkeModet
Celina Figueroa IP Consultant

ClarkeModet Argentina
Martín Roca International IP Senior Consultant

ClarkeModet Brasil
Leo Qi International IP Consultant

ClarkeModet España
This site is registered on wpml.org as a development site.