Regulatory Affairs
In CADERSO, we bear the “know-how” regarding the path of regulations & normativity in the pharmaceutical industry to operate adequately.
We intervene in the early development of the regulatory strategy and realize constant follow-ups to precisely customize, edit, fix & deliver the documents needed for the dossier.
Due to the experience of our work team, we ensure that the files comply with the strictest regulations both for COFEPRIS in Mexico and for other instances such as FDA, EMA, ANMAT, INVIMA, among others.
Regulatory Strategy
- Analysis of the current regulatory situation and generation of proposals for solutions and strategies that ensure the required certificates and registrations are obtained.
- The expertise of our collaborators helps reduce setbacks in the regulatory process.
Support and Backing
- Creation and Evaluation of Dossier
- New Product Registrations
- Extension and modification to the conditions of the Registry
- Operation Notices
- Changes of company name or manufacturers
- Resolution of audit findings
- Armed regulatory defense before committees
Experts in regulatory affairs, who developed in institutional positions during their professional practice, guarantee complete knowledge of the procedures to be fulfilled.