Regulariza Certo: Your Partner in Regulatory Compliance
Regulariza Certo is a specialized consulting firm dedicated to helping companies navigate the complex landscape of regulatory compliance in Brazil. With a focus on the medical devices, pharmaceutical, cosmetic, fertilizers, and veterinary product industries, we offer expert guidance in obtaining necessary licenses and authorizations from key regulatory bodies such as ANVISA (National Health Surveillance Agency) and MAPA (Ministry of Agriculture, Livestock and Supply). Our team of experienced professionals is committed to ensuring your business meets all legal requirements efficiently and effectively, allowing you to focus on what you do best – running your business.
LS
by Lucia Paula Ferreira Albanez Especialista em Direito Sanitário
Comprehensive Regulatory Services
1
ANVISA Compliance
Assistance with obtaining Operating Licenses and Company Operating Authorizations from ANVISA for various industries including pharmaceuticals, medical devices, cosmetics, and sanitizing products.
2
MAPA Regulations
Expert guidance on MAPA regulations for animal-origin products, veterinary medications, and agricultural inputs such as fertilizers and pesticides.
3
Product Registration
Support in registering, notifying, or listing products with ANVISA and MAPA, ensuring compliance with all regulatory requirements.
4
Customized Training
On-site training programs to educate your staff on health surveillance guidelines and good manufacturing practices.
The Regulariza Certo Advantage
Specialized Expertise
Our team focuses exclusively on health surveillance regulations, providing in-depth knowledge of ANVISA and MAPA requirements.
Multidisciplinary Approach
We employ a diverse team of experts including legal professionals, engineers, pharmacists, and healthcare specialists to address all aspects of regulatory compliance.
Proven Track Record
With over two decades of experience, we have successfully guided numerous companies through complex regulatory processes, ensuring timely approvals and certifications.
Understanding the Brazilian Health Surveillance System
1
ANVISA
The National Health Surveillance Agency is the primary regulatory body overseeing health products and services in Brazil.
2
Local Health Surveillance
State and Municipal Health Surveillance agencies work in conjunction with ANVISA to enforce regulations at the local level.
3
MAPA
The Ministry of Agriculture, Livestock and Supply regulates products of animal origin, veterinary products, and agricultural inputs.
4
Integrated Approach
Regulariza Certo navigates this complex system, ensuring compliance at all levels of regulatory oversight.
ANVISA Licensing Process
1
Local Operating License
Obtain a license from the local Health Surveillance authority (state or municipal) to begin operations.
2
ANVISA Authorization
Apply for Company Operating Authorization (AFE) from ANVISA for regulated activities such as manufacturing, importing, or distributing health products.
3
Product Registration
Once licensed, proceed with product registration, notification, or listing as required by ANVISA regulations.
4
Ongoing Compliance
Maintain compliance through regular renewals, updates, and adherence to Good Manufacturing Practices.
MAPA Regulatory Services
SIF Installation
Assistance in obtaining the Federal Inspection Service (SIF) seal for animal-origin products, enabling interstate and international trade.
Establishment Registration
Support in registering facilities for the production, import, or distribution of veterinary products, fertilizers, and animal feed.
Product Registration
Guidance through the process of registering animal-origin products, veterinary medications, and agricultural inputs with MAPA.
Compliance Monitoring
Ongoing support to ensure continued compliance with MAPA regulations and industry best practices.
Good Manufacturing Practices Certification
1
Preparation
Assessment of current practices and development of improvement strategies to meet GMP standards.
2
Documentation
Assistance in preparing comprehensive documentation required for GMP certification.
3
Application
Submission of GMP certification request to ANVISA or MAPA, depending on the product category.
4
Inspection
Preparation for and guidance through the regulatory inspection process.
5
Certification
Obtaining and maintaining GMP certification for ongoing compliance and market access.
Product Registration and Notification
Specialized Services for Food Industry
Local Licensing
Assistance in obtaining local Health Surveillance licenses for food production and distribution facilities.
ANVISA Registration
Support in registering food companies with ANVISA for electronic petitioning and product registration purposes.
MAPA Certification
Guidance in obtaining necessary MAPA certifications for animal-origin food products and beverages.
Regulatory Compliance
Ongoing advisory services to ensure adherence to evolving food safety regulations and standards.
Veterinary Product Regulations
MAPA Registration
Comprehensive support in registering fertilizers, veterinary pharmaceuticals, vaccines, and other animal health products with the Ministry of Agriculture, Livestock and Supply.
GMP Compliance
Assistance in implementing and maintaining Good Manufacturing Practices specific to veterinary product manufacturing facilities.
Import/Export Guidance
Expert advice on regulatory requirements for importing and exporting veterinary products, including necessary documentation and certifications.
Cosmetics and Personal Care Products
1
Product Classification
Determination of product risk grade (1 or 2) to identify the appropriate regulatory pathway.
2
Formulation Review
Assessment of ingredients against ANVISA's permitted substances list and concentration limits.
3
Notification/Registration
Submission of product notification for Grade 1 products or full registration for Grade 2 products.
4
Labeling Compliance
Ensuring product labels meet all ANVISA requirements for cosmetic and personal care items.
Medical Device Regulations
Risk Classification
Determination of the device's risk class (I, II, III, or IV) to identify the appropriate regulatory pathway.
Technical Dossier Preparation
Compilation of comprehensive technical documentation required for ANVISA submission.
Clinical Evidence
Assistance in gathering and presenting clinical data to support device safety and efficacy claims.
Post-Market Surveillance
Implementation of systems for ongoing monitoring and reporting of device performance and safety.
Pharmaceutical Regulatory Services
1
Pre-submission Strategy
Development of a comprehensive regulatory strategy tailored to your pharmaceutical product.
2
Dossier Preparation
Compilation of Common Technical Document submissions for ANVISA or MAPA review.
3
Clinical Trial Approvals
Assistance in obtaining necessary approvals for conducting clinical trials in Brazil.
4
Post-Approval Changes
Management of variations and updates to maintain compliance throughout the product lifecycle.
Customized Training Programs
On-Site Workshops
Tailored training sessions conducted at your facility to educate staff on relevant regulatory requirements and best practices.
Virtual Learning
Interactive online training modules designed to provide flexible, comprehensive regulatory education for your team.
Practical GMP Training
Hands-on training in Good Manufacturing Practices, tailored to your specific industry and production processes.
Regulatory Intelligence and Updates
1
Legislation Monitoring
Continuous tracking of changes in Brazilian health and agricultural regulations affecting your industry.
2
Impact Analysis
Expert interpretation of new regulations and their potential impact on your business operations.
3
Compliance Strategies
Development of tailored strategies to adapt to regulatory changes efficiently and cost-effectively.
4
Regular Briefings
Periodic updates and briefings to keep your team informed of relevant regulatory developments.
Partner with Regulariza Certo for Regulatory Success
Expert Guidance
Leverage our 20+ years of regulatory expertise to navigate complex compliance requirements confidently.
Accelerated Approvals
Benefit from our streamlined processes and strong regulatory relationships to expedite your product's path to market.
Risk Mitigation
Minimize compliance risks with our thorough understanding of regulatory nuances and potential pitfalls.
Business Growth
Focus on your core business while we ensure your regulatory compliance, supporting your company's expansion in Brazil.
Our Expertise and Team
Lucia Albanez - Technical Director
With over 20 years of experience in Regulatory Affairs, Lucia is a specialist in Health Law trained at FSP/USP and in Business Law at Mackenzie University. She leads a technical team of experts in Company Legalization, including chemical engineers, nurses, pharmacists, assistants, and interns.
Multidisciplinary Team
Our team combines practical and theoretical knowledge to offer quality service and concrete results for our clients. We understand the requirements and regulations of regulatory agencies and know how to guide our clients in the best possible way.
Contact
Regulariza Certo
Phone
+1 (201) 918 4555
WhatsApp
+55(11)91710-0012
Email
lucia@regularizacerto.com.br
Skype
lucia.albanez