Resultados de busca

MEDICINES MSSC offers full technical and legal support to companies operating in the field of Medicines. Regularization of companies ​ Before the start of operations, health product companies must be duly authorized by Organs health authorities, which includes (i) Operating License issued by the Local Sanitary Surveillance and (ii) Company Operating Authorization (AE) granted by ANVISA. Product records ​ ​ Medicine Registration (Specific, New, Similar. Generic) Registration of Biological and Hemotherapy Products; Registration of Active Pharmaceutical Ingredient (IFA); Medication Registration Renewal in general; Alteration of the Registration of Medicines in general. Certification of Good Manufacturing Practices/Storage and Distribution of Medicines (National and International). TALK TO US OTHER AREAS OF OPERATION COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

History Founded over 50 years ago by Dr. Maria Sponza, our office served the main names in the industry de cosmetics e sanitizing do Brasil. Team Marília Sponza Founder and Lawyer Carol Sponza Attorney Rachel Vial Biologist Jessica Toneli pharmaceutical ​Customers

Buy and Sell Certified Companies The entire process of regularizing companies before health authorities can take longer than your company's business speed. For this, we advise on the purchase and sale of companies already qualified for an immediate start of operations. TALK TO US OTHER SERVICES COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

COSMETICS Our services extends to all stages of the process, from the creation of the company to the final legalization of the products. Companies Before starting operations, cosmetics companies must be duly authorized by Sanitary and health authorities, which includes (i) Operating License issued by the Local Sanitary Surveillance and (ii) Company Operating Authorization (AFE ) granted by ANVISA. We assit your company in different states of Brazil. ​ Products Products must also be subject to registration or notification, according to their degree of risk, before the National Health Surveillance Agency (ANVISA). Some of our cosmetic services: ​ Operating License; Company Operation Authorization (AFE), for manufacturer, importer, distributor, warehouses and transportation companies of Cosmetic Products; Renewal of Operating License; Alteration/Expansion/Reduction of Activities in the Operating License and in the Company Operating Authorization (AFE); Other Changes in AFEs (eg Technical Responsible, Legal Responsible, address changes) Registration (risk II); and Notification (risk I) of products; Product Registration Renewal (risk II); Change of Registration/Product Notification. CONTACT US OTHER AREAS OF OPERATION COSMETICS LEARN MORE FOODS LEARN MORE SANITIZERS LEARN MORE HEALTH PRODUCTS LEARN MORE MEDICINES LEARN MORE

SANITIZERS Our advice extends to all stages of the process, from the creation of the company to the final legalization of the products. ​ Companies ​ Before starting operations, sanitizing companies must be duly authorized by sanitary agencies, which includes (i) Operating License issued by the Local Sanitary Surveillance and (ii) Company Operating Authorization (AFE) granted by ANVISA. We serve your company in different states of Brazil. ​ ​ Records/Notifications ​ Once the companies are regularized, the products must also be subject to registration or notification, according to their degree of risk, before the National Health Surveillance Agency (ANVISA) to then be sold to the final consumer. ​ Some of our services in Saneantes: ​ Operating license and renewal; Company Operation Authorization (AFE), for industry, importer, distributor, storage and transport of Sanitizing Products; Changes / in the Operating License and in the AFE; AFE changes (eg Technical Responsible, Legal Responsible, address changes) Registration (Grade II) and Notification (Grade I) of 12products; Registration Renewal (Grade II); Product Registration/Notification Change; Issuance of Free Sale Certificate for Products. Certification of Good Manufacturing Practices/Storage and Distribution of Sanitizing Products for products manufactured in Brazil. TALK TO US OTHER AREAS OF OPERATION COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

Registrations, Records, Licenses All products, after proper company regularization, must be Registered, Registered and/or Notified before the National Health Surveillance Agency (ANVISA). ​ After the approval of the Registration/Registration process has been published in the Federal Official Gazette (DOU - ANVISA Supplement), the company holding the registration is qualified to Manufacture or Import and distribute the product throughout the national territory. Setty Regulatory Affairs offers full technical and legal support for the Registration, Registration and Notification of its products. The following services are provided for the Registration, Registration and Notification of your Products: Medicines ​ Obtaining a Specific Medicine Registration with the National Health Surveillance Agency (ANVISA); Obtaining a New Medicine Registration with the National Health Surveillance Agency (ANVISA); Obtaining a Similar Medicine Registration with the National Health Surveillance Agency (ANVISA); Obtaining a Generic Drug Registration before the National Health Surveillance Agency (ANVISA); Obtaining the Registration of Biological and Hemotherapy Products before the National Health Surveillance Agency (ANVISA); Obtaining the Registration of Active Pharmaceutical Ingredient (IFA) before the National Health Surveillance Agency (ANVISA); Obtaining Renewal of Medication Registration in general before the National Health Surveillance Agency (ANVISA); Alteration of the Registration of Medicines in general before the National Health Surveillance Agency (ANVISA). cosmetics ​ Obtaining Grade II Cosmetic Product Registration before the National Health Surveillance Agency (ANVISA); Obtaining Grade I Cosmetic Product Notification from the National Health Surveillance Agency (ANVISA); Obtaining the Grade II Cosmetic Product Registration Renewal before the National Health Surveillance Agency (ANVISA); Change of Registration/Notification of Cosmetic Product before the National Health Surveillance Agency (ANVISA); Obtaining Free Sales Certificate for Cosmetic Products. sanitizing ​ Obtaining Risk II Sanitizing Product Registration before the National Health Surveillance Agency (ANVISA); Obtaining Risk I Sanitizing Product Notification from the National Health Surveillance Agency (ANVISA); Obtaining Renewal of Risk II Sanitizing Product Registration before the National Health Surveillance Agency (ANVISA); Alteration of Sanitizing Product Registration/Notification before the National Health Surveillance Agency (ANVISA); Obtaining a Certificate of Free Sale for Sanitizing Products. Foods ​ Obtaining the Registration of New Foods and New Ingredients before the National Health Surveillance Agency (ANVISA); Obtaining the Registration of Foods with Isolated Substances and Probiotypes with a functional and/or Health claim before the National Health Surveillance Agency (ANVISA); Obtaining a Child Food Registration before the National Health Surveillance Agency (ANVISA) Obtaining the Food Registration for Enteral Nutrition before the National Health Surveillance Agency (ANVISA); Obtaining the Registration of Recycled Food Packaging before the National Health Surveillance Agency (ANVISA); Obtaining Food Registration Renewal before the National Health Surveillance Agency (ANVISA); Amendment of Food Registration before the National Surveillance Agency; Adequacy of Labeling, Labeling Words and Nutritional Table of Foods submitted for Free Sale, in the manner required by the Consumer Protection Code and National Sanitary Legislation. TALK TO US OTHER SERVICES COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

FOODS Our advice extends to all stages of the process, from the creation of the company to the final legalization of the products. ​ Our team is ready to assist your company from creation to final obtaining all necessary health licenses. ​ For businesses: Sanitary License for the establishment, industry, importer, distributor, storage and transport of Food with the Local Sanitary Surveillance. ​ ​ Products - Registration / Notifications ​ Considering food products, both ANVISA and/or MAPA are responsible for survelillance. Anvisa: enteral foods, infant foods, among others. MAP: foods of animal origin such as milk, butter. ​ Some of our food services: Registration of New Foods and New Ingredients; Registration of Foods with Isolated Substances and Probiotypes with Functional and/or Health Claim; Infant Food Registry, for Enteral Nutrition; Registration of Recycled Food Packaging; Maintenance Registration Renewal and Amendment; Adequacy of Labelling, Labeling Words and Nutritional Table of Foods submitted for Free Sale, in the manner required by the Consumer Protection Code and National Sanitary Legislation. TALK TO US OTHER AREAS OF OPERATION COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

HEALTH PRODUCTS Health products are classified according to the intensive risk they represent to the health of the consumer, patient, operator or third parties, in Classes I, II, III or IV. For class a different procedure applies. Before the start of operations, health product companies must be duly authorized by health authorities, which includes (i) Operating License issued by the Local Sanitary Surveillance and (ii) Company Operating Authorization (AFE) granted by ANVISA. We serve your company in different states of Brazil. ​ Some of our services in Health Products: for companies : ​ ​ Operating License; Authorization and Renewal of Company Operation (AFE), for industry, importer, distributor, storage and transport of Health Products (Correlatos); ​ Alteration/Expansion/Reduction of Activities in the Operating License and in the Company Operating Authorization (AFE); General changes such as Corporate Name, Technical Responsible, Legal Responsible, address changes, etc., in the Company's Operating Permits (AFE). ​ For the products: ​​ Registration of Medical, Hospital and Dental Materials; Registration of Medical-Hospital Equipment, Dental Equipment, Electronic Equipment, Image Diagnosis Equipment, Hemotherapy and Labor Diagnostic Equipment; Registration of Sets, Reagents and Supplies intended for Diagnostics and radioisotopes for use in in vitro Diagnostics; Health Product Family Registration; Registration of Health Products; Renewal and amendment of Health Product Registration; Certification of Good Manufacturing Practices/Storage and Distribution of Medicines. TALK TO US OTHER AREAS OF OPERATION COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

Certifications of Good Practices (CBPF and CBPAD) In order for a company to be able to manufacture and import medicines or health products, the following certifications are required: ​ CBPF - Certification of Good Manufacturing Practices ​ → The Certificate of Good Manufacturing Practices (CBPF) is the document issued by Anvisa attesting that a given establishment complies with Good Manufacturing Practices. The Certificate is issued per manufacturing unit, covering the production lines, pharmaceutical forms, special therapeutic classes and/or risk classes of products for which the company was inspected. ​ CBPDA - Certification Good Distribution and/or Storage Practices ​ → The Certificate of Good Distribution and/or Storage Practices (CBPDA) is the document issued by Anvisa attesting that a given establishment complies with Good Distribution and Storage Practices or Good Storage Practices set out in the legislation in force. These Certifications are guarantees of quality by ANVISA, attesting that the activity carried out by the company is in compliance with the legislation. TALK TO US OTHER SERVICES COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

Legal Advice - Regulatory Law We have a large team of lawyers, specialized in health law and other areas of law necessary for companies working in this highly regulated market. Our team is constantly updated on the rapid regulatory changes of this sector. Our legal services include procedural analysis, compliance with the most diverse requirements, appeals, defense in case of infringements, etc. TALK TO US OTHER SERVICES COSMETICS KNOW MORE FOODS KNOW MORE SANITIZERS KNOW MORE HEALTH PRODUCTS KNOW MORE MEDICINES KNOW MORE

INÍCIO SERVIÇOS A EMPRESA Contato Soluções Personalizadas em Assuntos Regulatórios MSS Consultores: Assessoria regulatória full service para empresas que comercializam produtos para saúde, cosméticos, saneantes e alimentos, compreendendo toda a regularização necessária para adequação às normas e exigências da ANVISA, MAPA e INMETRO. SAIBA MAIS A EMPRESA We are focused on your company and your products We are the most traditional office specialized in Regulatory Affairs and ANVISA in Brazil. ​ Founded by Dr. Marília Sponza more than 50 years ago, we advise the main Brazilian and International companies in the area of cosmetics and sanitizing. ​ We are a multidisciplinary technical team, with full expertise not only on the technical aspects, but also on all legal areas, especially in health law. ​ Our goal is to facilitate all the procedures and permits necessary for your company before ANVISA and MAPA. SERVIÇOS EXPERTISE Our office advises the whole industry of cosmetics, sanitizing, food, health products and OTC medicines. ​ We assist manufacturers, importers, distributors and retailers since the beginning of their operation by obtaining the necessary licenses and authorizations for the company until compliance with all the standards and requirements of ANVISA and MAPA for the products. We are a team of highly specialized with multidisciplinary professionals with experience in Sanitary Surveillance, ANVISA, Foreign Trade, regulatory and tax law. ​ Consult our team and see how we can help your company better understand technical concepts. MISSION : To be a full service office in health law. EYESIGHT : To be a world reference in sanitary technical consultancy VALUES : Ethics Transparency Honesty Respect Record ​ We provide consulting services, technical assistance and follow-up of processes from formulation to full approval of products by ANVISA, State and Municipal Sanitary Surveillance and Class Councils. Consultancy and complete Technical Assistance for the Regularization of Companies and Products, including all the guidance for the adjustments necessary to comply with Good Practices in accordance with the health requirements set forth in the Legislation and Regulations. Training your team in Good Practices. Audits to verify compliance with the requirements of good practices in the corresponding product class. Class council ​ Registration of Company and Assumption and Change of Technical Responsibility in the corresponding class council. Health Surveillance (State and Municipal) ​ Initial License, License Changes and Revalidation. defenses National Health Surveillance Agency - ANVISA ​ Company Registration at ANVISA Alteration, updating of the registration and size of the company Operating Authorization (AFE) and Special Operating Authorization (AE); Initial Authorizations and Changes for all activities. Records, Notifications and Registration of Products: Medical Materials and Equipment (Health Products - Related), Food, Cosmetics and Sanitizing Alteration, Inclusion and revalidation of Registration. Certification of Good Manufacturing Practices, Storage and Distribution of Products under Sanitary Control by ANVISA. Consultancy and Assistance specialized in Import and Export of products subject to ANVISA approval, including the request for quotas and Import/Export Authorization for Products under special control. COSMETICS Our services extends to all stages of process, from the company creation to the final products legalization. LEARN MORE FOODS In the area of food, records are made at ANVISA and/or MAPA. Anvisa: enteral foods, infant foods, among others. MAP: source foods... LEARN MORE SANITIZERS Once the companies are regularized, the products must also be subject to registration or notification, according to their degree of risk, before... LEARN MORE HEALTH PRODUCTS Before starting operations, health product companies must be duly authorized by health agencies, which comp... LEARNMORE MEDICINES MSSC offers full technical and legal support to companies operating in the field of Medicines. For a company to... LEARNMORE Contato CONTACT Phone number: (21) 99956-0999 We'll answer you soon! To send

SERVICES Our team is prepared to assist your company in all diferent areas of expertise in law, such as tax planning, litigation and administrative law. In addition, we offer complete solutions for the most varied business formats Legal Advice Regulatory Law Certifications of Good Practices (CBPF and CBPAD) Registration Hosting Buy and Sell Certified Companies