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Mérieux -Bioagri: Steps into international market, stands out as a global leading CROqrcode

Oct. 26, 2017

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Oct. 26, 2017

Mérieux -Bioagri: Steps into international market, stands out as a global leading CRO

By Erwin Xue, business manager of AgroPages

AgroPages
: Could you please briefly summarise the global development of Mérieux NutriSciences-Bioagri, especially in China?
 
Roberto: Bioagri was founded in 1991 by professors from the Universidade de São Paul, which is one of the most prestigious universities in Brazil and Latin America.
 
With its level of scientific knowledge and good customer service, Bioagri became the main laboratory in Brazil and Latin America that conducts studies in agrochemicals for regulatory purposes, in several areas that include physical chemistry, toxicology, ecotoxicology, and environmental damage and residue.
 
Located in the second largest agribusiness market in the world, and experienced in providing quality services that cover the complete needs of Brazilian agrochemical companies, Merieux, under the BioAgri brand, decided to expand internationally. Part of this international expansion project was the launch of several initiatives to promote the company’s business relationships with international markets, such as in Argentina, China, India, Europe, Japan and other countries.
 
As China was increasing its presence as a manufacturer of active ingredients, the company decided to create a special business model dedicated to China, which focused on customer service, pre-screening and quality control analyses.
 
To better understand the needs of its customers, Bioagri established a local entity in Shanghai, which ensured a closer relationship with local customers while keeping track of regulatory changes in Brazil, other Latin America countries and the rest of the world.
 
The laboratory in Shanghai conducts preliminary analyses for the benefit of customers, such as pre-screening analysis of samples, to be submitted to a five-batch analysis GLP study in Brazil. As this pre-screening analysis is performed in China, it is possible to ensure the quality of sample before shipping to Brazil, then avoiding to realise any problem months later, after arranging all import procedures and performing pre-screening in the company’s GLP lab in Brazil.
 
The laboratory in Shanghai has fully met its expectations while offering a valuable service to customers. Besides pre-screening analysis the laboratory is accredited to ISO 17025 standards in terms of offering quality control and analyzing active ingredients and relevant impurities in agrochemical samples, to be exported to Brazil.
 
In 2011, Mérieux NutriSciences acquired Bioagri. As part of Institute Mérieux, Mérieux NutriSciences is dedicated to protecting the health of its consumers around the world, by delivering a wide range of testing and consulting services in the food and nutrition, agrochemical, pharmaceutical and cosmetics industries. With 50 years of experience in food safety and quality, and an extensive global presence with over 100 accredited laboratories in 21 countries, Mérieux NutriSciences is one of the leaders in the market.
 
Mérieux NutriSciences is committed to offering state-of-art studies for the registration of agrochemicals for registration in Brazil, Latin America and other OECD countries.
 
AgroPages: Could you please explain your major projects and special advantages over your industry rivals? As well as project efficiency, a professional team and a unique business model, please introduce your other core competences. 
 
Roberto: Mérieux NutriSciences offers complete data generation solutions for the registration of appropriate technical products and pesticide and bio-pesticide formulations. Our current internal capability allows us to conduct registration studies in any country that is part of the OECD Mutual Acceptance Agreement, such as Brazil, other Latin America countries, Mexico, the United States, Europe, Japan and most Asia countries.
 
Under a one-stop commitment, Merieux NutriSciences provides a full range of analyses and research services, such as five batch, physical chemistry, acute toxicology, eco-toxicology that includes honey bee studies, residue studies, strategic partnerships of efficacy and field residue studies required for technical products and formulations. Mérieux NutriSciences also performs studies for the registration requirements of new chemicals, such as environmental impact studies using radiolabeled materials and long-term chronic and sub-chronic toxicological studies.
 
Due to our long-term experience of conducting studies for submissions to Brazilian and other Latin American regulatory authorities, Mérieux NutriSciences is highly familiar with these authorities and can provide quick and assertive responses for any eventual requirements.
 
The unique expertise of Mérieux NutriSciences in five-batch analysis, developed over many years by a highly qualified working team to maintain quality in terms of procedures and reports, as well as the highest level of communication with research directors during the studies, or at any time due to unexpected requirements.
 
AgroPages: Are there any differences between the Chinese and other international markets? What successful experiences and service concepts can be shared with our readers?
 
Roberto: China is a unique market, considering that it has the largest number of manufacturers of technical products. As for success, we could mention many major Chinese manufacturers that succeeded in registering their products in Brazil, the European Union, México, the United States and other countries, through our studies and ongoing support.
 
An interesting case, which highlights the capacity of Merieux-Bioagri to facilitate global registration, was when we experienced an unexpected inspection by INMETRO, the Brazilian GLP regulator, following a request by the EPA. 
 
All the required data was quickly provided to the inspectors, who only took a couple of days to complete their evaluation. In the end, everything went perfect. This is, therefore, a good example of compliance and organization, which is only possible in a well-structured and organized GLP laboratory.
 
AgroPages: How does your company support your strategic partners in promoting their business?
 
Roberto: In our business, it is important to realise that providing support does not end once we issue the final report. Due to long-term evaluations by regulatory authorities and the unique requirements of various countries, we need to be ready to provide quick and adequate responses. It is normal to have to provide raw data on studies that were completed five or eight years ago, or even further back, from our archives, to promptly respond or amend reports, due to new or specific requirements.
 
With experienced and organised study directors, along with an effective quality and compliance company structure, we can meet our customers’ demands at any time. Mérieux NutriSciences offers valuable and unique support to customers, enhancing their commitment and reliability to their strategic partners.
 
AgroPages: What is the development plan of Merieux-Bioagri around the world and specifically in China for the coming years?
 
Roberto: We are well-positioned to conduct studies for registering technical products and formulations in Brazil and Latin America, considering the new lead times for EUP approval by Brazilian regulatory authorities. Therefore, we foresee our business development in terms of the three following areas:
 
i. International Expansion
 
The Brazilian EUP and import procedures for importing samples were a barrier for us, due to the time that it took for authorities to issue the document. However, since an electronic EUP was launched by the Ministry of Agriculture, this time has decreased from four to six months to about 20 days. Because of this, Mérieux NutriSciences has become more attractive to foreign companies that require quality GLP data for the worldwide registration of their pesticides and bio-pesticides.
 
Mérieux NutriSciences also offers comprehensive assistance services to customers for the import process.
 
Regarding our unique capabilities, expertise and experience in terms of performing environmental impact studies on 14C-radiolabeled materials since 2015, Mérieux NutriSciences has been successfully selling these studies to international companies that develop new chemicals as active ingredients.
 
As well as environmental impact studies, the company also offers long-term toxicology and reproductive studies, to meet the requirements of registering new active ingredients. 
 
ii. Biopesticides
 
Several factors, such as pest resistance to standard chemicals, along with major environmental concerns, biologic products, such bacteria, fungus and viruses, are increasingly employed for pest control in agriculture.
 
To be part of this trend while being able to offer a one-stop-shop solution to our customers, Mérieux NutriSciences can undertake physical-chemical, toxicological, ecotoxicological, and pathogenicity studies for biological products.
 
Therefore, besides promoting and improving our studies on technical products and formulations, Mérieux NutriSciences’s strategy is to invest in innovation and provide excellent customer service.
 
iii. Innovation Projects
 
Mérieux NutriSciences is conducting a series of innovation projects, to launch studies that can satisfy new regulatory requirements.
 
Regarding the agrochemical sector, it has implemented innovative studies according to market demands, such as on biopesticides as stated previously, or new regulatory requirements, such as alternative methods for toxicological studies and risk assessment studies on agrochemicals for pollinators.
 
As well as the agrochemical sector, Mérieux NutriSciences conducts studies for other sectors, such as on food analysis, the environmental sector, the pharmaceutical industry and consumer goods.

About Roberto Sardinha

Roberto Sardinha is a chemist, with 13 years of experience in Bioagri (Mérieux) performing GLP studies of agrochemicals, with strong knowledge and experience on five batch analysis, and physical chemistry obtained after 10 years ahead of chemistry division. He is responsible for international sales and technical support for domestic sales, besides with development of new services to meet new regulatory demands or customer needs. 
Source: AgroNews

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