CTD dossier: scientific excellence for global regulatory submissions
The global standard for drug registration
The CTD (Common Technical Document) is the internationally harmonized format for drug registration, adopted by agencies such as EMA, FDA, and ANVISA. Since 2016, with Brazil's entry into ICH, this format has become a mandatory reference for regulatory submissions.
It organizes all technical, clinical, and quality information
of the drug, facilitating assessment and speeding up the approval process.
Quality > Safety > Effectiveness
The complete structure of the CTD
CTD requires highly qualified specialists
At Synvia, this process is led by a team with a solid academic background – composed of masters, doctors, and post-doctors specialized in scientific writing, pharmacology, clinical development, and regulation.
Our work integrates methodological rigor, multidisciplinary review
and practical experience in national and international submissions, ensuring robust, consistent dossiers aligned with the highest
regulatory standards.
Shortcut: agility and technical robustness in the registration of medications
The abbreviated pathway allows for the accelerated registration of medicines based on consolidated scientific literature, without compromising quality, safety, or efficacy.
It is especially applicable to medicines with a broad history of use or that already have robust evidence in other regions.
A Synvia
Regulatory excellence in national and international records
Synvia operates in an integrated manner throughout all phases of the drug life cycle — from clinical research to laboratory analyses, toxicology, and digital solutions.
With more than 20 years of experience, we combine scientific rigor, regulatory intelligence, and state-of-the-art infrastructure to expedite submissions without compromising compliance.
Agility and predictability
in deadlines
Our processes are structured to ensure fast and consistent deliveries, with teams dedicated to the development and review of CTD dossiers.
Our deadline governance ensures predictability, reduces rework, and accelerates national and international submissions.
