LUTSAN SOLUTIONS

LUTSAN SOLUTIONS provides all specialties of Pharmaceutical consultancy to the MENA region within Quality Assurance, regulatory affairs and Pharmacovigilance services to all clients in pharmaceuticals/healthcare fields, and assist them at each step of the specific regulatory process to manage their timely launch of pharmaceuticals, Cosmetics, food products and medical devices in the MENA region. We evaluate information and material to ensure that it is complete and of suitable quality to be submitted to the authorities, prepare the requirements for submissions in CTD, NeeS and eCTD format based on Authorities requirements and regulations and will provide a Compliance Services that Create Operational Excellence including compliance evaluation, critical issue remediation and resolution, risk assessment analysis, supporting system design and deployment, gap analysis, publishing, and much more. Yet helping clients meet regulatory obligations is only the beginning of our services. On the path to regulatory compliance, we identify areas where operations and processes can be improved with simple, cost-effective solutions, ensuring maximum efficiency and quality along with product and regulatory integrity. LUTSAN SOLUTIONS has specific capabilities tailored to address issues associated with planning and managing change that the pharmaceutical and health care industry witnesses constantly because of producing new, innovative products and technologies to improve and prolong people's lives. LUTSAN SOLUTIONS has experience for preparing companies for regulatory inspections and are fully familiar with SFDA regulations (as well as EMA & FDA regulations).