Eder Lorenzato Junior, Msc. Email & Phone Number

State Of São Paulo, Brazil

Campinas, São Paulo, Brasil

Responsible for leading the restructuring of the Organic Chemistry department, increasing efficiency and productivity. Responsible for leading the establishment of a process for prospecting API manufacturers aimed at selecting technically fine manufacturers with reduced costs and time, defining selection schedules, minimum requirements for technical documentation, and conducting technical discussions to assess economic viability. Responsible for leading the implementation of innovative… Show more Responsible for leading the restructuring of the Organic Chemistry department, increasing efficiency and productivity. Responsible for leading the establishment of a process for prospecting API manufacturers aimed at selecting technically fine manufacturers with reduced costs and time, defining selection schedules, minimum requirements for technical documentation, and conducting technical discussions to assess economic viability. Responsible for leading the implementation of innovative research and development tools, such as toxicity prediction software and ASAP protocols. Evaluation and prospecting of new API manufacturers through rigorous analysis of Drug Master Files (DMFs). Development of strategies for impurity control in APIs and finished products, including studies to predict potential degradation products, propose degradation routes, comparative impurity profiling, and analyze interactions between APIs and excipients.Preparation of risk assessement for elemental impurities, nitrosamines, and inclusion of new API manufacturers. Active participation in the registration and post-registration processes of APIs and drugs, conducting internal or external meetings with partners to ensure compliance with deadlines and technical requirements of regulatory documents. Support to pharmacotechnical development, analytical development, pre-formulation, DMF, and regulatory affairs departments. Responsible for monitoring and ensuring compliance with new legislation, staying updated on sector changes and requirements. Show less

Conducting comprehensive evaluations of Drug Master Files (DMFs) and ensuring regulatory compliance for obtaining CADIFA. Providing guidance to international API manufacturers regarding the new regulatory framework concerning the CADIFA and cCBPF acquisition processes. Leading initiatives to follow up with API manufacturers to expedite documentation for registration and post-registration phases. Responsible for proactively identifying and evaluating new API manufacturers, expanding… Show more Conducting comprehensive evaluations of Drug Master Files (DMFs) and ensuring regulatory compliance for obtaining CADIFA. Providing guidance to international API manufacturers regarding the new regulatory framework concerning the CADIFA and cCBPF acquisition processes. Leading initiatives to follow up with API manufacturers to expedite documentation for registration and post-registration phases. Responsible for proactively identifying and evaluating new API manufacturers, expanding the supplier network. Developing meticulous risk assessement to enhance decision-making processes. Providing vital support to pharmacotechnical development, analytical development, pre-formulation, and regulatory affairs. Facilitating the smooth implementation of new regulations, ensuring continuous compliance. Active participation in the registration and post-registration processes of APIs, conducting internal or external meetings with partners to ensure adjustments to deadlines and technical requirements of regulatory documents. Successfully restructuring the DMF department, optimizing efficiency. Show less

Campinas E Região, Brasil

Conducting rigorous assessments of Drug Master Files (DMFs) and Drug Intermediate Files (DIFAs) to ensure compliance with regulatory standards. Leading follow-up activities with API manufacturers to align documentation for registration, demonstrating a proactive approach to regulatory requirements. Developing in-depth technical studies predicting potential degradation products and proposing degradation routes for APIs.Implementing robust impurity control strategies, including… Show more Conducting rigorous assessments of Drug Master Files (DMFs) and Drug Intermediate Files (DIFAs) to ensure compliance with regulatory standards. Leading follow-up activities with API manufacturers to align documentation for registration, demonstrating a proactive approach to regulatory requirements. Developing in-depth technical studies predicting potential degradation products and proposing degradation routes for APIs.Implementing robust impurity control strategies, including investigations of impurities beyond specified limits, structural elucidation, and comparative profiling. Providing critical support for pharmaceutical development, regulatory affairs, and analytical development teams. Active participation in the registration and post-registration processes of APIs, conducting internal or external meetings with partners to ensure adjustments to deadlines and technical requirements of regulatory documents. Drafting comprehensive responses to regulatory demands from national and international authorities. Responsible for structuring and implementing the internal training schedule and legislation studies, demonstrating dedication to continuous improvement. Conducting various training sessions, ensuring team proficiency and compliance with industry standards. Show less

Valinhos

Evaluation of Drug Master Files (DMFs) and Drug Intermediate Files (DIFAs) for regulatory comply.Theoretical evaluation of degradation pathways, interactions between APIs and excipients, as well as structural elucidation of impurities or degradation products.Reviewing pre-formulation, development, and validation studies conducted by third parties, ensuring methodological rigor. Providing crucial support to pharmacotechnical development and regulatory affairs departments… Show more Evaluation of Drug Master Files (DMFs) and Drug Intermediate Files (DIFAs) for regulatory comply.Theoretical evaluation of degradation pathways, interactions between APIs and excipients, as well as structural elucidation of impurities or degradation products.Reviewing pre-formulation, development, and validation studies conducted by third parties, ensuring methodological rigor. Providing crucial support to pharmacotechnical development and regulatory affairs departments, contributing to a cohesive workflow. Executing forced degradation studies in compliance with RDC 53/2015, ensuring adherence to regulatory standards. Leading the development and validation of analytical methodologies, enhancing accuracy and reliability. Drafting comprehensive responses to regulatory requirements, demonstrating proficiency in compliance matters. Actively participating in the acquisition of new laboratory equipment aligned with company demands, showcasing a proactive role in enhancing analytical capabilities. Show less

Américo Brasiliense

Conducting rigorous validation of analytical methodologies, ensuring accuracy and reliability in testing processes. Validating cleaning procedures and overall process validation, contributing to manufacturing quality assurance. Proficiently developing and analyzing analytical documentation related to method validation and cleaning validation, maintaining compliance with industry standards. Executing pharmaceutical product stability studies, contributing to the assessment of their… Show more Conducting rigorous validation of analytical methodologies, ensuring accuracy and reliability in testing processes. Validating cleaning procedures and overall process validation, contributing to manufacturing quality assurance. Proficiently developing and analyzing analytical documentation related to method validation and cleaning validation, maintaining compliance with industry standards. Executing pharmaceutical product stability studies, contributing to the assessment of their shelf life and quality over time. Show less

Master’S Degree, Pharmaceutical Science

Mestrado Titulo: Desenvolvimento de uma plataforma modelo para a busca de ligantes com potencial leishmanicida baseado na inibição.

Bachelor’S Degree, Pharmacy

Iniciação Científica Titulo: Análogos de acilidrazonas fenólicas antifúngicas: planejamento, síntese e investigação preliminar de relações.