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
Optimization of product development through regulatory strategy.
Tailored for each type of medicinal product and Legal Basis.
Team with experience in innovative developments, including Biologics and ATMP
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.
Meet the drug team: technical services
Find the right expert to offer you customized solutions.
ClarkeModet España
ClarkeModet Paraguay
ClarkeModet Brasil
ClarkeModet Brasil
ClarkeModet España
ClarkeModet Uruguay
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.
