Product registration
MAPA/ANVISA/CTNBio
Registration of veterinary products: pharmaceuticals, biologicals and disinfectants.
Registration of cosmetic products (hygiene and beauty)
Registration or listing of products for animal feed: ingredients, additives, supplements, feed.
Registration of sanitizing products classified as risk level 2
Notification of risk level 1 sanitizing products
Services
Strategic analysis of product framing (fast-track/innovation, provisional licensing, others)
Strategic analysis and requirements planning (Checklist)
Evaluation of existing studies and gaps
Preparation and submission of registration dossier.
Product lifecycle analysis and necessary adjustments for license maintenance.
Monitoring the registration steps
Technical administrative resources.
International business
Product registration in countries of the Americas
Strategic analysis, assembly, submission, and approval of veterinary products, animal feed, and sanitizing products in the countries of the Americas, enabling the export of these products.
Some of the countries we serve.
Central America (Central American Regulation)
Argentina
Bolivia
Canada
Chile
Colombia
Ecuador
Mexico
Paraguay
Peru
Uruguay
United States
Among others (please inquire)
Business Registration
Commissioning and evaluation of compliance with Good Manufacturing & Control Practices requirements.
Obtaining the necessary sanitary licenses and permits to operate in Brazil.
Evaluation & implementation of Quality Systems.
Audits.
Studies for registration
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Clinical and laboratory studies
Evaluation of requirements and study protocols
Study monitoring
Report reviews
Audits/monitoring of GPC in clinical trials
Developing partnerships with CROs and laboratories to conduct studies in Brazil and LATAM countries.
In-company training
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Training
Technical development and training for quality, regulatory, and production teams.
