Regulatory Documents Editing & Filing
eCTD & eRPS Documents Editing
CODEX Scientific prepares eCTD and eRPS or certain sections of eCTD and eRPS according your needs. We help you in writing the Module 2 with the non-clinical and clinical summary and overview. We have particular expertise in the preparation of the pharmacokinetic and pharmacodynamic (2.5.2 and 2.7.2), clinical efficacy (2.5.3 and 2.7.3), and clinical safety parts (2.5.4 and 2.7.4), but also of the nonclinical modules (2.4.3, 2.4.4 and 2.6.4, 2.6.5 and 2.6.6).
eCTD & eRPS Documents Filing
CODEX Scientific offers full-service, eCTD & eRPS submission support. The process includes compilation and organization of the submission using a standardized submission software solution. We perform quality controls on each document within the submission to ensure compliance with established electronic document standards and also to validate the combined submission before uploading. During the publishing and submission process, CODEX Scientific works closely with you to ensure that the submission is complete and timely, and that it meets both your expectations and regulatory requirement.
