During the last years the pharmaceutical industry in Brazil, went through important transformations. We have seen the growth of national companies – leveraged in large part by the production of generic drugs – the repositioning of foreign industries – as a result of new technologies for the production of biological medicines – and the proliferation of public-private partnerships. These transformations had on the background changes of government and still the reflections of the last global recession.

We noted with concern the departure of specialized engineering companies in the pharmaceutical market and the creation of a large gap in the segment. Many of the professionals in the business have changed their activity or left the country in search of opportunities.

In 2019 we are closely monitoring the pharmaceutical regulatory framework and the harmonization of Brazilian standards with international standards through participation in PIC/S and ICH. This normative change will certainly come accompanied by the need for business adequacy and consequent demand for specialized consulting services.

In short, the pharmaceutical engineering market in Brazil is increasingly dynamic and companies working in this segment need to adapt in the same way. That is why Nordika do Brasil has decided to invest part of its best resources in the creation of a consulting division specialized in solutions for the pharmaceutical industry – welcome to Nordika Consulting.

The main objective of Nordika Consulting is to offer services of high added value, developed by highly qualified professionals. We are prepared to offer the following specialized activities:

  • Feasibility Studies and Conceptual Projects;
  • GMP Assessment;
  • Gap Analysis of engineering projects;
  • Due Dilligence in pharmaceutical plants;
  • Representation of the client in management contracts – Owners Representative;
  • Internal Audits directed to specific topics;
  • Audits in Third Parties;
  • Risk Analysis;
  • Training through the Nordika Academy program.

 

Contact us and find out how we can help you.

Silmas Pareico Architect and Urban Planner, MBA in International Relations by Fundação Getúlio Vargas. Works on the development and design management of pharmaceutical engineering projects since 1997. Experienced in Conceptual, Basic and Detailed Design for drug production and quality areas. Has worked in local and international projects for clientes such as Eurofarma, Biolab, Rousselot, Bayer, Kley Hertz, Roche, Bio Manguinhos, Gross, Bio-Merieux, Abbott, Knoll e Merck.
Bruno Lima Graduated in Pharmacy, Master in Pharmaceutical Sciences, in the area of ​​nanotechnology and development of new pharmaceutical forms by the Federal University of Minas Gerais. Active member of the PDA chapter Brazil. Experience in the pharmaceutical industry, in the areas of coordination and elaboration of processes, formulation of injectables, equipment qualification and process validation. With highlights for the Biomm, Eurofarma and Blau projects as well as consultancy on Good practices for Biomanguinhos and Takeda.
Cristiano Ferrari Graduated in Electrical and Mechatronics Engineering, and an MBA from FGV. He has 20 years of experience in automation projects in pharmaceutical and biotechnology industries. Specialized in development of automation projects for GAMP, CFR21Part11 and Validation oriented BPx environments. Has developed automation systems for process control, filling machines, inspection, washing and sterilization, CIP / SIP, packaging, BMS, FMS, MES, SCADA, in projects of Novo Nordisk, Libbs, Bionovis, Orygen, Fresenius, Biochimico, Butantan. During last years, leading the digital transformation in the pharmaceutical industry. Participated on the elaboration of Data Integrity – Manufacturing Records RDI Good Practice Guide from ISPE. He is the GAMP Brazil Committee Leader and member of the ISPE SIG Pharma 4.0
Mario Brenga Graduated in Industrial Administration and Computer Science. Participated in the elaboration of ANVISA’s Computerized Systems Validation Guideline. ISPE authorized speaker for GAMP5 training, Mario has 20 years of experience and has participated in large-scale projects for companies such as Novo Nordisk, Shire, AstraZeneca, Pfizer, among others.
Ana Marie Kaneto Electrical Engineer and Civil Construction Technologist, has been working in the pharmaceutical industry for 15 years, with experience in design qualification, commissioning, equipment qualification, utility systems and automation systems. In the last 8 years she coordinates, manages projects and gives training and lectures on Good Documentation Practices, Equipment Qualification, Design Qualification and Computerized Systems Validation for Automation. It is part of the Commissioning and Qualification CoPs and GAMP. Treasurer Director ISPE Brasil 2019/2020.