After due regularization of the company, it is mandatory to register each product prior to its commercialization inside the Country. 

Setty Regulatory Affairs offers complete technical and legal support for the Registration and notification of company’s products. Services provided for products Registrations and notifications are: 

Medicine

• Obtain a Specific Drug Registration;
• Obtain a New Drug Registration;
• Obtain a Similar Drug Registration;
• Obtain a “Generico” Drug Registration;
• Obtain a  Biologic or Hemotherapeutic Registration;
• Obtain the Active Ingredient Registration;
• Registration Renewal;
• Post Approval Medicine alteration.   

Medical device

• Obtain a Medical Device registration;
• Obtain an in vitro product registration;
• Obtain sets, reagents and radioisotopes for use in in vitro diagnosis registration; 
• Post approval alteration processes;

Cosmetics

• Obtain cosmetics Grade II registration;
• Obtain cosmetics Grades I and II notification;
• Post approval alterations processes;
• Obtain a Free Sale Certificate;

Sanitizing products

• Obtain Sanitizing Product Risk I Notification 
• Obtain Sanitizing Product Risk II Registration;
• Sanitizing Product Risk II renewal;  
• Post Approval alteration processes;
• Free Sale Certificate for Sanitizing Product;

Food products

• Obtain a new food product registration;
• Obtain a new ingredient registration; 
• Obtain an isolated substance or probiotics food products registration;
• Obtain functional or Health claim food products registration;
• Obtain enteral feeding products registration;
• Obtain recycled food packaging registration;
• Food Product registration renewal;
• Post approval alteration processes;
• Label and nutritional table adequacy for food products free of registration.