Majo Villarraza

Your FDA Regulatory Expert and US Agent. Our bilingual team of experienced FDA consultants and partners provides comprehensive guidance in both English and Spanish, ensuring professional and effective communication to help your business achieve FDA compliance and regulatory objectives. With in-depth knowledge of the USA market, including medical, distribution and pharmacy channels, we aid your company in developing new studies grounded in solid scientific evidence, fostering the promotion and commercialization of your products. Clients can leverage our years of expertise and our professional, dependable approach to business. Pharma 4.0 FDA Registration Services delivers customized solutions to address all your requirements. Consulting Services: • Offer counsel on product claims & regulatory affairs, reviewing packaging, advertising, marketing & educational materials. • Guide on import processes, and help in obtaining clearance for products through U.S. Customs and FDA at the time of entry. • Work with marketing and R&D teams to ensure claims compliance while emphasizing the company’s products' competitive edge. • Inform manufacturers about new and evolving state and federal regulations, clarify implications, and recommend proactive mitigation strategies. • Conduct precise and thorough assessments of U.S. cosmetic and OTC drug labeling and packaging artwork.

R&D, QbD, RRAA and Launch Support for Pharmaceutical Synthetic&Biologic Products in LATAM/US. Transfer Technology of Company products to LATAM&US. Regulatory Affairs and Scientific Support in LATAM. &US .

Role of the AACC: - Identify barriers and opportunities in bilateral trade of goods and services - Create spaces for useful netwrking betweeen USA and Argentine companies and individuals - Facilitate connections with official and private organizations in USA

R&D and Launch of more than 100 Pharmaceutical, Dietary and Cosmetic Products. Transfer Technology of Company products to Argentina, Mexico and Brazil. Regulatory Affairs and Scientific Support for Marketing Claims.

R&D and launch of more than 200 pharmaceutical products in Argentina, Uruguay, Paraguay, Perú, Ecuador, México, Vietnam, Indonesia, China, Thailand, Czeck Republic, Ukraine, Azerbaijan, Kazakhstan, Turkmenistan and Slovakia among others.

Organization of Quality Control and Quality Assurance Lab and Team. Responsible of ANMAT/INAME GMP inspections Technical Audits according to local and global cGMP's.

In charge of Regulatory Affairs, Registration and Launch of a complete Biologic&Cytostatic&Rare Diseases Pharmaceutical Line.

Analysis: Flow cytometry, ELISAs, PCRs, Immunoassays and other techniques of Molecular Biology.

CEMECO: Analysis for Diagnosis and classification of Congenital disorders of glycosylation.

Machine Learning in Business / NLP and Robotics in Business/ Artificial Intelligence in Business and its future.

* Academic Director of PostDegree Courses: Regulatory Affairs Pharmaceutical Manufacturing and Engineering Pharmaceutical Biotechnology Medical Technology Strategic Management of Pharmacies

Premio Universidad (Summa Cum Laude)

Prescription Drug Regulation, Cost, and Access: Current Controversies in Context

Molecular Foundation of Medicine: PCR, CRISPR, Genomic Edition, DNA recombination.