CTD Dossier (Common Technical Document) development, sourcing and registration solutions.
CTD Dossier for more than 12 therapeutic area.
CTD Dossier developed
Does manufacturer monthly
CTD Dossier; development, sourcing and registration solutions.
At CurePharma, we provide expert CTD (Common Technical Document) dossier development, sourcing, and registration solutions, guiding you through every step of the regulatory process. Our comprehensive approach covers all five modules of the CTD: Module 1 (Administrative Information and Prescribing Information), Module 2 (Summaries), Module 3 (Quality), Module 4 (Nonclinical Study Reports), and Module 5 (Clinical Study Reports). We meticulously prepare and source each module to meet global regulatory standards including MHRA, FDA, and EU requirements, ensuring a seamless and efficient submission process. Partner with us to achieve timely approvals and bring your pharmaceutical and nutraceutical products to market with confidence.
Solutions
Dossier development
Dossier sourcing
Registration solutions
Submission
MHRA, FDA, and EU standards
Therapeutic areas
Immunology
Oncology
Cardiology
Neurology
Endocrinology
Clinical solutions
At CurePharma, our clinical solutions are designed to support the development of comprehensive CTD (Common Technical Document) dossiers, ensuring compliance with global regulatory standards like those of the MHRA, FDA, and EU. We provide end-to-end services for compiling the clinical sections of the CTD, specifically Modules 2, 4, and 5, which include clinical summaries, nonclinical study reports, and clinical study reports. Our approach integrates rigorous clinical research with meticulous documentation, ensuring that each dossier is complete, accurate, and ready for submission. Partner with us to streamline the regulatory process and successfully bring your products to market.
Non-clinical summaries M2
Clinical summaries M2
Non-Clinical study reports M4
Clinical study reports M5