TEVAH Consulting, based in Brazil, specializes in regulatory and government affairs, as well as the registration of agricultural and biotechnological products, including biopesticides, biofertilizers, micronutrients, biostimulants, soil correctives, inoculants, genetically modified plants (GM), GM microorganisms, GM animals, and products derived from New Breeding Technologies (NBT).
OTEVAH consultants, with over 25 years of experience acquired in academic institutions and the agricultural biotechnology industry, are prepared to guide your company through the complex process of obtaining the authorizations required by CTNBio, transforming your laboratory concept into a commercial product.
Development of biosafety manuals. Biosafety training for CIBio members and employees (initial and annual). Annual biosafety inspections required by CTNBio. Biosafety inspections of GMO studies in laboratories or fields. Development of detection kits involving PCR, qPCR, and antigen-antibody reactions (ELISA and Western Blot), molecular biology, and immunochemistry, among others.
Preparation of regulatory dossiers for the commercial registration of hybrids, varieties, biological and chemical products, biofertilizers, micronutrients, biostimulants, soil correctives, inoculants, genetically modified products, medicines, medical devices, vaccines, food additives, and agricultural products.
Preparation of commercial dossiers and submission to CTNBio. Monitoring the process in Brasília, DF. Responding to requests for additional information and clarifications. Registration with MAPA, IBAMA, and ANVISA as per applicable regulations.
AMonitoring of inspections and audits by Regulatory Agencies. Advisory support for company defense in case of fines. Assistance and consultancy in the implementation of necessary corrective actions. Batch analysis for evaluation of biological products using molecular biology methods for lot release.
Sérgio Ricardo Nozawa, Ph.D.
Consultant in Regulation, R&D, Stewardship, Discovery, Science, and Institutional Affairs for biotechnological products, such as medicines, vaccines, microorganisms, and food additives aimed at animal health, human health, and agriculture. Ph.D. in Molecular and Cellular Biology and Chemistry. He has over 20 years of experience in genomic research in multinational companies such as Dow AgroSciences (Corteva) and Allelyx (Monsanto), as well as universities in Brazil and the United States and the Ministry of Science, Technology, and Innovation. He participated in the Genome Project and the development of RNAi technology for agriculture and human health (vaccines).
Fabiano Santos Ferreira, M.Sc.
Consultant in Regulation, R&D, Stewardship, and Registration of hybrids, varieties, microorganisms, pesticides, biological and biotechnological products. Agronomist Engineer and Master in Genetics and Plant Breeding, with over 25 years of experience in companies such as Dow AgroSciences (Corteva) and Monsanto (Bayer).
Monica S. F. Nozawa, Ph.D.
Consultant in Regulation, R&D, Discovery, Science, and Laboratory Studies for biotechnology, medicines, vaccines, food additives, and products aimed at animal health, human health, and agriculture. Biologist, Ph.D. in Genetics, and Post-Doctorate in Biochemistry and Immunology. More than 20 years of experience in research in Genetics, Cellular and Molecular Biology, participation in the Xanthomonas citri Genome Project and Cancer Genome Project, development of patents, and publication of articles and book chapters. She was Vice-Rector of Research and Graduate Studies and participated in Ethics in Research and Biosafety Committees.