Marco Antonio is an experienced and highly specialized consultant with a “right first time” vision for each project, clearly focused on clients’ need to meet their objectives with the higher chance of success, but at the same time optimizing clients’ resources and time.

Marco Antonio is a pharmacist by training, with a PhD in Pharmaceutical Development and Master’s Degree in Regulatory Affairs, as well as Post-Graduate Specialist Degree on Industrial and Galenical Pharmacy.

Marco Antonio has more than 20 years of experience in the pharmaceutical field, both in public and private sectors, where he has worked at the Spanish Medicines Agency (AEMPS) and the European Medicines Agency as CMC advisor and at the European Directorate for the Quality of Medicines and Healthcare (EDQM) as European Pharmacopoeia Expert, as well as at responsibility positions in the Regulatory Affairs department of Pfizer Spain.

In 2008, following his prominent and extensive professional experience, Marco Antonio founded the consultancy company, Moreno-Saturnino Regulatory & Quality Assessors, S.L. with the initial objective of giving scientific support to very specialized and highly technical regulatory aspects, a field that has not always traditionally been adequately addressed with the necessary level of detail and required qualifications by the majority of the existing consultancy companies in this sector. 

Since then, Marco Antonio has been working as a senior Regulatory Affairs and CMC consultant for all sort of pharmaceutical companies, from small biotech companies, such as Sanifit Therapeutics (leading all CMC pathway for a new chemical entity as SVP Manufacturing since end of Phase 1 until end of Phase 3 and for the transition to MAA, now under CSL Vifor since the acquisition in January 2022), and Apta Targets (CMC consultant for oligonucleotides / aptamers development for stroke since Phase 1 and currently at end of Phase 2a), to small, medium size and big pharma companies, such as AstraZeneca, Roche, Pfizer, Novartis, or CSL Vifor among others, for new proprietary, essentially similar and authorized medicinal products, as well as for nutraceuticals and food supplements. Marco Antonio is collaborating with MGA Business Consulting, S.L. as Senior CMC & Regulatory Consultant. 

Specialties : Allies with clients for the design of regulatory strategy and regulatory intelligence plans. Conducts CMC due diligences within the frame of companies, full product portfolios or specific assets acquisitions. Design and execution of contingency and risk minimization plans for CMC related issues. Full support in the elaboration and execution of CMC development plans for new medicinal products since early pre-clinical stages up to marketing authorization  submission. Mock assessments of CMC sections to check regulatory compliance prior to NDA/MAA submissions and QOS elaboration. License maintenance activities including consultancy on tech and analytical transfers, as well as for variations categorization, pre-assessment and submission strategies. Customized in-house training for high level and/or highly specialized Regulatory Affairs and CMC related topics.