CDR Consult

We have a team of Regulatory Affairs specialists with extensive experience preparing dossiers for Regulatory Authorities such as the EMA, FDA, PMDA, NMPA, ANVISA, and others, ensuring compliance with international and local regulations.

• We optimize file preparation, reducing review times and avoiding regulatory rejections.

• We prepare documents tailored to each country's regulations, ensuring full compliance.

• We provide comprehensive support from data collection to the preparation of the CTD or eCTD according to the requirements of the health authorities that accept or require this format.

• We have extensive experience in preparing Modules 4 and 5 of the CTD, conducting bibliographic searches, writing, structuring, and reviewing all preclinical and clinical study documentation for the dossier.