New Drug Applications (NDAs) and Biologic License Applications (BLAs): Curedose Pharma prepares comprehensive NDAs and BLAs, ensuring that all necessary data (clinical, preclinical, CMC, etc.) is presented in accordance with FDA, EMA, or other regulatory requirements.
Marketing Authorization Applications (MAA): We support clients in the submission of MAA to the EMA, ensuring that the application meets European regulatory requirements.
Investigational New Drug Applications (IND): We assist in submitting IND applications for early-phase clinical trials to the FDA, ensuring all preclinical data and trial protocols are included for review.
Abbreviated New Drug Applications (ANDAs): For generic drugs, we help prepare ANDA submissions, including bioequivalence studies, manufacturing information, and labelling compliance.
Clinical Trial Applications (CTAs): We help submit CTAs to regulatory bodies such as the EMA or Health Canada, ensuring compliance with clinical trial regulations for human testing.
Orphan Drug Designation and Paediatric Investigational Plans: We provide support for obtaining orphan drug status or developing pediatric investigational plans (PIPs) to ensure early regulatory engagement for rare or paediatric drugs.
