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Regulatory strategy that opens the path.

Soluto Regulatórios

Soluto Regulatórios designs and carries out the regulatory strategy for the product and the company, so the operation takes the right path at the Brazilian Health Regulatory Agency (Anvisa) from the start.

Strategy comes before the filing.

Soluto Regulatórios analyzes the client's product and business and designs the path at Anvisa: which regime applies, which licenses the company needs and which quality system supports the operation. It has worked since 2008, in Vinhedo, São Paulo, and is the company around which the group was formed.

Who it is for

Companies and products subject to health surveillance, in these segments:

  • Pharmaceutical
  • Health products
  • Cosmetics
  • Food
  • Veterinary and agro
  • Chemicals and sanitizers
  • Logistics operations

The risk class decides the path.

For health products, Anvisa handles classes I and II through notification and classes III and IV through registration. Soluto checks the product classification and chooses the route before building the dossier.

The rule applies to health products. Medicines, cosmetics and other products follow the rules of each category.

Notification

Class ILow risk

Class IIMedium risk

Registration

Class IIIHigh risk

Class IVMaximum risk

Source

How Soluto works.

  1. Analysis

    We map the product, the business model and the regulatory scenario, with risks and timelines.

  2. Route

    We define the path: notification or registration of the product and the licensing the company needs to operate.

  3. Dossier

    We prepare the technical dossier and follow the process through to Anvisa's decision.

  4. Post-registration

    Changes, renewals and technical requirements stay under follow-up throughout the life cycle.

Soluto opens the group journey.

  1. Starting point

    Receives the client's product and operation, with the question that decides the rest: which path to regularize through.

    Soluto Regulatórios

    Regulatory Strategy

  2. Hands over to Ávita Care

    Hands over the defined route. With it, Ávita Care holds the registration and represents the operation in the country.

    Marketing Authorization Holder & Compliance

  3. Technology & Automation

  4. Market Access

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Which regulated sectors Soluto Regulatórios works in: Regulated sectors

How Soluto Regulatórios takes part when the company comes from outside Brazil: Foreign companies in Brazil