Product Registration
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.
Biosafety Quality Certificate (CQB)
Application for new CQB, submission of CQB extensions for other locations, species, and facilities, modifications, and cancellations of CQB.
Internal Biosafety Committee (CIBio)
Advisory services for the creation of CIBio. Communication of changes in CIBio composition. Coordination of CIBio meetings. Annual report to CTNBio. Response to biosafety incidents and accidents.
Standard Operating Procedures (SOP)
Development of SOPs for experimental procedures with genetically modified organisms (GMOs). Review and updates of SOPs for GMO studies.
Training, Development, and Inspections
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.
Molecular Biology
Validation of molecular biology kits. Validation of morphological identification of microorganisms using molecular biology. Real-time PCR and PCR analysis. DNA sequencing (Sanger and NGS).
Experimental Use Permits (EUP)
Planning of studies and experimental designs. Preparation and submission of EUP applications. Monitoring of efficacy studies and risk assessments, in field and laboratory. Communication and submissions to CTNBio during experiment execution. Preparation of the final EUP report and submission to CTNBio.
GMO Import and Export
Submission and monitoring of GMO import/export applications with CTNBio. Obtaining approvals for GMO import and export with IBAMA and MAPA. Coordination and tracking of import/export processes until customs clearance. Obtaining acceptance letters from quarantine centers. Submission of quarantine exemptions in accordance with IN 52/2018.
Studies for Regulatory Dossiers
Molecular and genetic characterization of GMOs and non-GMOs. Risk assessment for human and animal health for GMOs and non-GMOs. Environmental risk assessment for GMOs and non-GMOs. Toxicological and allergenic risk assessments using Bioinformatics. Efficacy studies (GMOs and non-GMOs). Biodegradability studies (GMOs and non-GMOs). NTO studies. Protein expression studies. Agronomic studies. Determination of CFU levels in biological products. Preliminary toxicological and environmental classification of pesticides, including warning phrases, hazard words, and pictograms, in compliance with GHS guidelines. Qualitative-quantitative composition assessment, aligned with current legislation, establishing minimum and maximum limits for active ingredients and permissible components. Monitoring of laboratory studies: toxicological, ecotoxicological, and physicochemical. Technical discussions with study directors. Preparation of Technical Reports on agronomic, product registration, efficacy assessment, and residue studies.
Commercial Release Submissions
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.
Post-Commercialization Monitoring
Development of post-commercialization monitoring plans for biotechnological products. Execution of post-launch monitoring programs for biotechnology products. Annual reports and final reports to CTNBio. Communication of biosafety incidents and development of mitigation plans.
Inspections and Audits
Monitoring 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.
Good Laboratory Practice (GLP) Accreditation
Production monitoring with validation of protocols for large-scale production involving bioproduction technologies (bioreactors), methane gas bioproduction, antibody vaccine bioproduction (human and animal), and biomolecule bioproduction for agriculture (RNAi). Preparation of necessary documents for Accreditation of Proficiency Testing Providers, in accordance with ABNT NBR ISO/IEC 17043 requirements. Preparation for INMETRO inspections. Advisory services for preventive and corrective measures. Real-time PCR and PCR analysis. DNA sequencing (Sanger and NGS).
Accreditations and Certifications
Accreditation and certification of laboratories, greenhouses, and experimental field areas in accordance with applicable Normative Instructions, such as IN 36/42 (agricultural pesticides), IN 53 (biofertilizers), among others. Accreditation of establishments for manufacturing, experimentation, storage, import, and export of agricultural products, whether packaged or in bulk.
Quality Assurance and Product Management
Preparation of Management Programs, monitoring, registration, and documentation of testing activities under Management. Conducting inspections of experiments conducted under Management. Application of LEAN to regulatory processes. Implementation and operation of Quality Management Systems (QMS) in biotechnology processes, both in the laboratory and in the field. Continuous review and improvement of the company's QMS.
Biodiversity Authorization and Information System (SISBIO)
Obtaining authorizations in SISBIO for agricultural pest collection and maintenance of authorizations, in accordance with Normative Instruction No. 169 of IBAMA (02/20/2008) and Normative Instruction No. 03 of MMA (09/01/2008).
Genetic Heritage Management Council (CGEN)
Obtaining authorizations from the Genetic Heritage Management Council (CGEN) for the use of Brazilian biodiversity and maintenance of authorizations, in accordance with Law No. 13.123, of May 20, 2015.
Institutional Affairs
Interactions with major Brazilian universities, such as USP, UNESP, UNICAMP, UNB, and research institutes like Fiocruz, the National Institute for Amazonian Research, the Butantan Institute, and Embrapa, among others. Collaborations with international universities and institutes, such as Texas A&M, University of Oklahoma, Purdue University, Institute of Molecular and Cellular Biology, and University of Porto, among others. Monitoring regulatory processes in Brasília with agencies such as CTNBio, MAPA, IBAMA, and ANVISA. Scheduling meetings with Ministers, Executive Secretaries, Departments, Divisions, etc. Direct engagement and discussions within the Legislative and Executive branches. Participation in associations. Technology transfers and Public-Private Partnerships (PPP).
New Technologies
Development of innovative technologies using New Breeding Techniques (NBT) for applications in agriculture (pest control, disease resistance, weed management, and increased productivity), environmental solutions (waste treatment and bioremediation), and bioenergy.