Quality

Meeting the most strict Brazilian and International standards

Certified in Good Manufacturing Practices (cBPF) granted by ANVISA since 2002 and by the Food and Drug Administration (FDA) since 2016, Nortec Química is proud to have facilities and documentation system that meet the most strict Brazilian and international standards. The more than 50 Active Pharmaceutical Ingredients manufactured by Nortec Química have a complete DMF (Drug Master File), registered in several Regulatory Agencies around the world, and they are being updated to the CTD (Common Technical Document) format. In 2019, Nortec Química started a process to obtain CEP (Certificate of Suitability to the monographs of the European Pharmacopeia) for its entire APIs, starting with Prilocaine.

Constantly Developing Team

Nortec Química’s team is constantly developing and updating new regulatory trends. The quality of its APIs is ensured through the development and validation of analytical methodologies, including official compendia, such as the American and European Pharmacopeias, critical process parameter analysis, attribute control of starting material, raw material and finished products.

High Tech Equipment

Stability tests are carried out according to current legislation, meeting other climatic zones, as required by its customers. The company also has state-of-the-art equipment with software-managed chromatographs that meet the requirements of FDA CRF21 Part 11.

Excellence in Quality

The company’s Excellence in Quality is constantly recognized by its clients and class entities. With more than 250 clients, the company has an internal audit and ongoing external audits.

Best Recognition Programs

The company is part of the best Supplier Qualification recognition programs of Brazilian and multinational pharmaceutical companies, such as: Sanofi Premium Program, Takeda Assured Quality Certification (Nycomed), Aché Supplier Certification Program and Sindusfarma Quality Award.

Constantly Developing Team

Nortec Química’s team is constantly developing and updating new regulatory trends. The quality of its APIs is ensured through the development and validation of analytical methodologies, including official compendia, such as the American and European Pharmacopeias, critical process parameter analysis, attribute control of starting material, raw material and finished products.

High Tech Equipment

Stability tests are carried out according to current legislation, meeting other climatic zones, as required by its customers. The company also has state-of-the-art equipment with software-managed chromatographs that meet the requirements of FDA CRF21 Part 11.

Excellence in Quality

The company’s Excellence in Quality is constantly recognized by its clients and class entities. With more than 250 clients, the company has an internal audit and ongoing external audits.

Best Recognition Programs

The company is part of the best Supplier Qualification recognition programs of Brazilian and multinational pharmaceutical companies, such as: Sanofi Premium Program, Takeda Assured Quality Certification (Nycomed), Aché Supplier Certification Program and Sindusfarma Quality Award.

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