Explore the Brazilian market for Farmaceutical Products
What is it?
Kivalita assists companies that seek to market their finished products or APIs in Brazil, facilitating business with Anvisa and adapting processes to Brazilian GPx.
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Kivalita Differential:
Complete team and complete process
We have a multidisciplinary and bilingual team, made up of international auditors, regulatory affairs experts and quality managers.
Who is it for?
Explore the Brazilian market for Farmaceutical Products
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How can we help?
Before achieving GMP certification, it's of the utmost importance to set the correct strategy, that's why you can count on our multidisciplinary team to help you out.
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Gap Analysis
A wide and profound online diagnosis which points out gaps that must be closed before Anvisa inspection, stop you from trading in Brazil, or even improvement opportunities.
- Kivalita analyses all documentation involved in the process remotely;
- Kivalita team make interviews and carry out a virtual inspection;
- Gap Analysis report is made based on Risk Analysis tool;
- A meeting to show found Gaps and how Kivalita can help to close them.
After this broad evaluation, it is necessary to act on the corrections.
Continuous K
CONTINOUS K is the contribution of our specialists to manage the action plans for eventual corrections in the processes. This package covers:
- Weekly meetings to solve gaps found in the process;
- Effective management of training considering company strategies;
- GPx assistance in the conduct of actions.
- Training of up to 2 hours each quarter.
After the corrections, it is necessary to move on to regulatory affairs.
Regulatory Affairs
What are the processes to be a supplier in Brazil?
In Brazil, medicines, medical devices and other health products are submitted to Anvisa, which dictates all the legislation to be followed by companies that want to operate, both as an importer and as API suppliers.
- Regulatory support required for licensing in Brazil
- Local representative for pending resolutions with Anvisa
- Regulatory affairs support and consulting throughout the process
We serve the following processes:
- Stability test for zone 4
- Clinical testing if obsolete
- Registration of the product by Anvisa
- Registration of API in Brazil (CADIFA)
- Assistance in the process of opening a company in Brazil
Audit
We have the best professionals in the market, with full knowledge in current legislation in Brazil, with experience in audits in India, China and South America.
We understand the entire inspection process of Anvisa, so that you do not make erroneous investments when it comes to obtaining your certification / License.
We specialize in:
RDC 658 March 2022 – Good Manufacturing Practices for Pharmaceuticals.
RDC 362 March 2020 - Criteria for certification of Good Manufacturing Practices and institutes the inspection program for international establishments manufacturers of active pharmaceutical ingredients.
RDC 166 July 2017 - Validation of Analytical Methods
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We have plenty of experience in solutions for Pharmaceutical Industries, Pharmaceutical Importers and Pharmaceutical Distributors.