Solange Bautista

Solange Bautista is a regulatory affairs analyst at CorralRosales with experience in Regulatory Affairs, specializing in pharmaceuticals and medical devices. She also provides regulatory support for other product categories, including food products and dietary supplements.

Her practice focuses on regulatory portfolio supervision, as well as the filing and monitoring of sanitary registrations before the National Agency for Regulation, Control and Health Surveillance (ARCSA). She participates in the review and validation of technical and regulatory documentation to ensure compliance with applicable health regulations and provides technical support and advisory services in processes related to operating permits, Good Manufacturing Practices (GMP), Good Storage, Distribution and Transportation Practices (BPADT), pharmacovigilance, technovigilance, and other regulatory requirements applicable to pharmaceuticals, medical devices, food products, and dietary supplements.

Previously, she served as a Regulatory Affairs Analyst, where she provided technical and regulatory support in pharmaceutical and medical device registration and maintenance processes, as well as assistance in quality control, document verification, and compliance with Good Manufacturing Practices (GMP) and Good Storage, Distribution and Transportation Practices (BPADT).

Solange earned her degree in Pharmaceutical Biochemistry from the Central University of Ecuador and maintains continuous professional development in pharmacovigilance and regulatory affairs.