Take the Next Step Towards Excellence and Compliance
Are you ready to transform your company’s quality management and ensure compliance with standards and regulations? Regulatory offers personalized and effective solutions tailored to your specific needs.
Our team of experts is ready to help you:
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Obtain the necessary licenses and permits to operate legally.
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Empower your team with specialized training.
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Optimize your processes and achieve operational excellence.
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Prepare your company for audits and inspections.
CONTACT FORM
Regulatory Affairs
Ensure the essential regulatory framework for your company to operate safely in national and international markets. We support your business in obtaining authorizations and certifications through a practical, agile process aligned with the best technical standards to guarantee regulatory compliance and facilitate your entry and sustained presence in key regulatory environments.
Trainings
Invest in your team’s knowledge through training in Quality Management Systems and related standards. We offer various training programs focused on ISO standards interpretation, Risk Management, Project Management, Internal Auditor Training, and Quality Tools. We also provide customized training tailored to your business needs.
Audits
Count on our Quality Management System audit services to ensure continuous process improvement. We conduct Internal Audits, Business Partner Audits, and Gap Analysis, identifying opportunities for improvement and compliance adjustments. Our specialists focus on your products and processes, providing an integrated and strategic view of your operations.
Quality Management Consulting
Transform your company’s quality management with our specialized consulting services. We perform a comprehensive organizational diagnosis, identifying improvement opportunities and implementing customized solutions.Our consultants work closely with you to optimize workflows, processes, and infrastructure, defining key performance indicators (KPIs) and monitoring results in practice.
Excellence in Quality Management
Enhance your company’s quality and compliance with Regulatory. We are experts in consulting, training, and auditing for quality management systems (QMS), ISO standards, Good Practices (GMP), and international regulations — with a strong focus on the life sciences sector. We deliver customized solutions tailored to your company’s specific needs, ensuring regulatory compliance and preparing your organization for audits, inspections, and product certification.
Rely on our expertise to achieve excellence in your processes.
Introducing Our CEO and Her Commitment to Continuous Improvement
Founder and CEO – Commitment to Excellence
Fernanda Borba Martins – Industrial Biochemical Pharmacist graduated from Pontifical Catholic University of Paraná, with a specialization in Quality Management from the Federal University of Paraná.
Certified Quality Auditor for ISO 13485, ISO 22716, ISO 9001, and Good Manufacturing Practices (GMP). Over 20 years of professional experience in regulatory affairs and quality management within life sciences companies. Specialist in validations, special processes, and controlled environments – CEO of Regulatory Quality Consulting.
Regularize your company and products for operation in national and international markets.
Obtain Operating Authorizations, Sanitary Licenses, and Product Registrations, ensuring compliance for commercialization in Brazil.
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Quality Management: ISO 13485, MDSAP, MDR, ISO 22716, ISO 9001, Good Manufacturing Practices (GMP), Storage and Distribution.
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Targeted and systemic consulting services.
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Training programs.
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First-party and second-party audits.
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Regulatory affairs.