Complete veterinary regulatory solution for your business in Brazil.
We offer regulatory solutions, with the aim of simplifying and assisting the marketing trajectory of veterinary companies.
SM Regulatory is a business complex highly specialized in Regulatory Solutions for various sectors.
With the One Stop Shop concept, we offer integrated strategic and operational solutions, combining technical expertise and regulatory knowledge. Our vast experience allows us to meet the diverse needs of the value chain in a safe and efficient manner, providing peace of mind and compliance for your business.
The complete regulatory solution for your business in Brazil
Since 2017, SM Regulatory Solutions has been a trusted partner in the veterinary market. Formed by a group of regulatory affairs experts, our team brings extensive experience in national and multinational companies. We are here to offer customized solutions that meet all your regulatory needs.
Whether it is for outsourcing regulatory activities, licensing establishments and products, or support in any requirement of MAPA - Ministry of Agriculture and Livestock , we have the necessary expertise to help your company successfully navigate the regulatory sector.
Count on us to make your company's journey easier and more straightforward.
Mission
Identify and provide regulatory solutions aimed at customer satisfaction, accessibility to information, simplifying the marketing trajectory of veterinary companies.
Vision
To be a facilitator of regulatory services for veterinary companies, which do not have an organizational structure for the regulatory affairs area, so that we can help and simplify the concepts and possibilities of registering products and establishments.
Values
Focus on developing simplified solutions.
Assist in the marketing trajectory of veterinary companies as a team.
Innovate and Evolve the Veterinary Sector.
Regulatory Solutions
Integrated regulatory solutions to accelerate your business
Brazilian Market
Structuring companies in Brazil
Regulated Market
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We operate throughout the regulated chain
Additional Services
Market Strategy and New Business Development
Food
Animal
Additive
Complete food
Adjuvant food
Specific foods
Concentrated
Ingredients
Core
Premix
Portion
Supplements
Products of
Animal Origin
Meat
Milk
Eggs
Fish
Honey
Derivatives
Products for Veterinary Use
Antiparasitics
Antibiotics
Anesthetics
Anti-inflammatories
Endectocytes
Homeopathic
Vitamins
Vaccines
Diagnostic Kits
Hygiene and Beautification
Shampoos
Rinses
Creams
Room Spray
Perfumes
Odorizers
Regulatory Management
SM provides support services in the form of Corporate Regulatory Management .
In this type of project, the technical and regulatory structure related to the type of activity carried out is analyzed with the purpose of guiding companies on the legal requirements that ensure their regular operation.
Deadline management
Support in fulfilling ancillary obligations
Assistance in the traceability of information and documents
License renewal
Registration renewal
Related activities
On-demand consulting
Strategic Planning
SM provides consultancy for the strategic planning of companies operating in segments regulated by the Ministry of Agriculture and Livestock - MAPA , carrying out detailed market studies according to the client's needs.
In this work, it is observed:
The existence of competing and similar products regulated in the national market
Contraindications, warnings and instructions for use of registered products
Manufacturers and registration holders
Distributors and their geographical location
The purchasing target audience
Alternatives for starting operational activities
Business licensing
Companies that carry out any activities in the areas of animal health and animal feed must be regulated by the Ministry of Agriculture and Livestock – MAPA .
SM operates throughout the country and has solid experience in regularizing:
Licensing of Manufacturers of Veterinary Products (Pharmaceuticals and Biologicals)
Licensing of Animal Feed Manufacturers
Licensing of Importers, Exporters, Warehousers, Distributors and Traders
Factory or warehouse expansion
Address changes
Transfer of ownership of establishment
Implementation and performance of Audit procedures
Regulatory consultancy
SM's differential is the way in which the Regulatory Affairs Consulting service is carried out.
Through intelligent operational management and a specialized multidisciplinary technical team, we offer the dynamism and customization required by the reality of business, ensuring the creation of individualized solutions for each client in the diagnosed scenario.
In our model we analyze the needs, carry out the diagnosis, develop the project, plan the activities and execute the work.
Our way of doing consultancy is focused on:
Technical reliability
Procedural quality
Speed of response
Solid Base of Values
Compliance Policy
Product regularization
SM provides guidance, analysis and preparation of dossiers for product regularization with the aim of ensuring the viability of commercialization with quality, speed and safety.
With experience in notification, registration and product registration with MAPA , the SM team is competent to carry out work with all classes of products, respecting the particularities in conducting processes for each client.
Initial regularization of national and imported products
Records, registrations and notifications
Technical framing and grouping
Definition of strategies for product regularization
Technical and regulatory feasibility analysis
Regulatory due diligence
Due Diligence is a process of investigation and auditing of company information, essential to confirm the data made available to potential buyers or investors in an M&A (Merger and Acquisitions) process.
This process has clear variations depending on the nature of the business and the size of the company. Basically, Due Diligence refers to financial, accounting, and tax issues, as well as legal, corporate, and regulatory aspects.
For this operation to be successful, the SM team contributes to assessing the liability related to regulatory issues, ensuring impartiality, security and better understanding of the regulatory strategy for the M&A operation.
Interface with CMDO with internal and external market
Third Party Production Contracts (CMDOs) play a crucial role in the veterinary sector by allowing companies in the segment to outsource the manufacturing of their products to specialized partners.
This provides greater operational flexibility, cost efficiency and access to cutting-edge technologies, without the need for significant infrastructure investments.
We act as a strategic interface in Brazil and globally, facilitating partnerships between veterinary companies and third-party manufacturers that meet the rigorous regulatory and quality standards required by the market.
Our expertise enables veterinary products to be manufactured, registered and distributed efficiently, ensuring compliance with local and international regulations.
Additionally, we offer comprehensive support throughout all phases of the process, from selecting the ideal partner to contract management and quality audits, strengthening our clients’ global operations.
Team training
At SM Regulatory Solutions , we offer a full suite of services to empower and enhance the performance of teams in the veterinary sector. Our team training is geared towards preparing professionals in specific regulatory topics, ensuring they are up to date with best practices and market requirements.
In addition, we carry out continuous monitoring, monitoring the practical application of the knowledge acquired and providing support in administrative and operational routines, so that companies keep their activities aligned with current standards and optimize their processes.
We also offer assistance in selection processes, through pre-interviews that help identify the most suitable candidates for roles in the veterinary sector, facilitating the choice of professionals with the ideal skills and profile to contribute to the company's success.
Our goal is to provide integrated solutions that not only improve individual performance, but also raise the bar for the entire operation, ensuring compliance and efficiency.
Main Segments
Pharmaceutical
With solid experience in regulation and licensing of pharmaceutical-grade veterinary products, our project management at SM Regulatory ensures the execution of all activities in a safe, agile, personalized and exclusive manner, where technical excellence, commitment, process quality, efficiency in response time and ethics consolidate SM Regulatory as a reference in the regulated market.
Biological
At SM Regulatory Solutions, we have extensive experience in the regulation and licensing of biological veterinary products. Our project management ensures that all activities are carried out in a safe, agile and personalized manner, meeting the specific characteristics and requirements of this segment.
Hygiene and beautification
With extensive experience in large companies in the sector, SM Regulatory offers complete solutions to enable the regularization of products in the Brazilian market (local manufacturing, import and export), meeting all the specificities of the Hygiene and beautification segment.
Animal Food
At SM Regulatory Solutions, we offer extensive regulatory expertise for snacks, pet foods, supplements and additives, ensuring that pet industries meet all legal requirements.
Our specialized team provides support from obtaining the Operating License from MAPA to ensuring compliance with product quality and safety standards. With an agile and personalized approach, we provide complete support so that companies can operate safely and effectively in the regulated pet food market.
Products of Animal Origin
At SM Regulatory Solutions, we have expertise in regulating animal products, such as meat, milk, eggs, fish, honey and derivatives. We offer complete support, from obtaining the Operating License from MAPA to compliance with quality and safety standards.
Our agile and personalized approach ensures that your products are ready for market, meeting all legal requirements.
Come grow with us!
CONTACT
Contact us:
Fill out the form below and one of our consultants will contact you.
Address:
Antonio Artioli Avenue, 570
Films Building, Block B1, Suite 119, Room 67
Swiss Park - Campinas - SP