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Soluto Regulatórios

OUR SERVICES

Complete Regulatory Solutions.

From strategic planning to final approval. Integrated technical expertise to guide your product through the regulatory pathway with safety and predictability.

PORTFOLIO of SERVICES

Each service is designed to solve specific challenges in your regulated business.

Regulatory Management

We manage the entire regulatory lifecycle: deadline monitoring, license renewals, requirements compliance and continuous interface with regulatory bodies.

Strategic Regulatory Planning

Scenario analysis, risk mapping and strategic roadmap for entering the Brazilian market. Timeline and investment simulation.

Company Licensing

Operating Authorizations from ANVISA, MAPA, IBAMA, Federal Police, Army, Sanitary Surveillance, City Halls and Environmental Agencies.

Regulatory Consulting

Methodology: Analysis → Diagnosis → Project → Planning → Execution. Multidisciplinary team and customized solutions.

Quality Management

Implementation and maintenance of management systems aligned with regulatory requirements. Preparation for audits and inspections.

Product Registration

Registration, notification and product filing with ANVISA. Complete technical dossier preparation and follow-up until approval.

Post-Registration Activities

Changes, additions, renewals and registration maintenance. Follow-up on technical requirements and regulatory adjustments.

GMP Certifications

Good Manufacturing Practice certification, preparation for ANVISA inspections and compliance with ISO standards and specific certifications.

Compulsory Certification & Foreign Markets

Liaison with certification bodies — INMETRO, ANATEL and the other compulsory certifications your product requires.

In-Company Training

Team training in regulatory affairs, compliance and good practices. Customized programs for specific needs.

Regulatory Due Diligence

Regulatory compliance analysis for M&A, investments and partnerships. Identification of regulatory risks and opportunities.

Corporate Restructuring & M&A

Regulatory strategy for mergers, acquisitions, spin-offs and demergers — without stopping the operation.

Ready to structure your regulatory path?

Our team of experts is ready to understand your needs and design the ideal strategy for your business.

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