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

w Dossier development

w Dossier sourcing

w Registration solutions

w Submission

w MHRA, FDA, and EU standards

Therapeutic areas

w Immunology

w Oncology

w Cardiology

w Neurology

w 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.

test-tube Non-clinical summaries M2

atom-2 Clinical summaries M2

medicine Non-Clinical study reports M4

test-tube-big Clinical study reports M5

Solutions for neural problems

*Electrical signals in the brain

New technology to improve lives

*Electrical signals in the brain

Genomic data and bioinformatics

*Electrical signals in the brain

01
Administrative and prescribing information

*Integration system

02
Overview and summary of modules 3 to 5

*Integration system

03
Quality (pharmaceutical documentation)

*Integration system

04
Preclinical (pharmacology/toxicology)

*Integration system

05
Clinical – efficacy and safety (clinical trials)

*Integration system

Get tailored job offers based on your interests

    At CurePharma, Our dedication and commitment have led us to some of the most important discoveries in the field of dossiers development and clinical trailers. If you need help to develop your dossiers get our guide

    If like to speak to our technical team to develop your dossier you can call us on 0044 1937 339995 or email us on npd@curepharma.co.uk