Hire Moro Alberto, a pharma consultant specializing in Clinical Studies, Drug Development, FDA Inspections and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: Italy
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Dr. Alberto Moro is a Qualified Person and senior pharmaceutical consultant with more than 25 years of experience across API manufacturing, process chemistry, analytical development, Quality Assurance, Regulatory Affairs, supplier auditing, GMP training, and inspection management. His career combines deep scientific expertise in API synthesis and process development with practical responsibility for DMF preparation, regulatory deficiency responses, deviations, change control, OOS management, equipment qualification, cleaning validation, supplier qualification, and regulatory inspection readiness. He has worked across both API and finished-dosage-form manufacturing environments and has participated in multiple AIFA, FDA, and other international inspections. - Show More
Dr. Moro supports API process development through extensive experience in synthetic-route development, analytical-method development, process scale-up, industrialization, and technical troubleshooting for active pharmaceutical ingredients. As an R&D Manager in an API manufacturing company, he managed the development of synthetic and analytical methods in line with ICH Q11 principles and supported the transfer of laboratory processes into commercial manufacturing. His earlier experience as a senior chemist in API synthesis, together with his contribution to several pharmaceutical process patents, gives him a strong scientific foundation for helping companies improve process robustness, scalability, impurity control, and regulatory readiness.
Dr. Moro supports FDA warning letter remediation through comprehensive assessment of quality, manufacturing, laboratory, supplier, validation, and regulatory systems. His combined background in Quality Assurance, Regulatory Affairs, API process development, and inspection management makes him especially relevant for remediation projects involving serious or recurring GMP deficiencies. He helps organizations align corrective actions with actual process risks, regulatory commitments, and sustainable system improvements, particularly where findings involve API chemistry, process controls, analytical methods, DMF information, or inconsistencies between filed documentation and manufacturing practices.
Dr. Moro supports FDA-483 response and remediation by helping organizations investigate observations, identify systemic root causes, develop corrective and preventive actions, and prepare clear and scientifically justified responses. His experience in managing deviations, change control, OOS, recalls, equipment qualification, cleaning validation, supplier qualification, and regulatory deficiencies allows him to assess whether an observation reflects an isolated problem or a wider weakness in the pharmaceutical quality system. He helps companies build practical remediation plans that address immediate risks while also strengthening long-term compliance and inspection readiness.
Dr. Moro supports GMP audits for API manufacturers, starting-material suppliers, and pharmaceutical facilities through a practical and scientifically informed approach. His current consulting activities include supplier audits and inspection management, while his previous responsibilities covered self-inspections, vendor qualification, Quality Assurance oversight, equipment qualification, deviations, change control, OOS, and cleaning validation. His strong technical background enables him to assess both the procedural adequacy of a quality system and the scientific suitability of the manufacturing and analytical controls supporting the product.
Dr. Moro supports GMP training through practical, experience-based programs tailored to API manufacturing, Quality Assurance, Regulatory Affairs, laboratory operations, supplier oversight, and inspection readiness. His current consulting activities include GMP training courses, while his previous QA roles included responsibility for personnel training management. His training can help organizations strengthen understanding of deviations, investigations, CAPA, change control, OOS, supplier qualification, equipment qualification, cleaning validation, documentation practices, regulatory commitments, and the relationship between process development, GMP, and API quality.
Dr. Moro supports mock FDA inspections by helping pharmaceutical and API manufacturing sites identify compliance gaps before an official regulatory inspection. His experience includes active participation in several FDA and AIFA inspections and direct involvement in inspection management, Quality Assurance systems, regulatory documentation, and technical responses. He helps organizations evaluate inspection readiness across documentation, deviations, CAPA, OOS, equipment qualification, cleaning validation, supplier controls, and consistency between actual manufacturing practices and information filed in regulatory dossiers.
Dr. Moro supports regulatory filing through direct experience preparing and managing EU ASMF and US DMF documentation for active pharmaceutical ingredients. His work has included technical support for new submissions, preparation of manufacturing and control information, response to deficiencies raised by regulatory authorities, and support for technical questions from pharmaceutical customers. His combined expertise in process chemistry, Quality Assurance, and Regulatory Affairs allows him to ensure that regulatory submissions accurately reflect the actual manufacturing process, analytical controls, starting materials, intermediates, and GMP systems used at the site.
Dr. Moro supports supplier qualification through GMP auditing and risk-based assessment of API suppliers, starting-material manufacturers, intermediates producers, and other critical vendors. Supplier auditing forms part of his current consulting work, and his previous QA responsibilities included direct management of supplier qualification and audit programs for both API and finished-dosage-form manufacturing operations. He helps companies evaluate supplier quality systems, manufacturing controls, regulatory history, data integrity, deviation handling, change-notification practices, and material traceability before initial approval or periodic requalification.
