CROs and Regulatory Processes: Interview with Staphyt’s Fanny Vanel
24 July 2022 AgriBusiness Global reached out to Fanny Vanel, Marketing and Communications Manager of Staphyt, to get her perspective on major challenges formulators currently face. Vanel, who’s been with Staphyt since 2014, shares her thoughts on the product approval process, working with formulators around regulatory blocks, and Staphyt’s recent expansion into new regions.
ABG: What do think are the major challenges for the current regulatory process?
FV: In Europe, product registration is highly complex and is one of the major challenges in both traditional synthetic chemistry and biocontrol sectors. It is therefore essential to have a very high level of experience and expertise at both regional and country levels in Europe to ensure success — and not even the largest companies attempt to cover all topics and geographies. This is where expert consultants like Staphyt play a critical role in the deliverance of business objectives for all types of manufacturers in this market.
In Brazil, the product registration process is also complex, as it’s a tripartite system: the Ministry of Agriculture is responsible for issuing the registration, but approvals come from ANVISA (Ministry of Health) and IBAMA (Ministry of Environment). One of the most critical points in the Brazilian process is the timeline to get approval. Products have taken an average of 4-5 years after submission to receive approval for an equivalent technical product. In the final months of 2021, a new decree was published highlighting some important points to speed up this process, making it more efficient, but still following all the technical rigor to guarantee the safety for both people and the environment.
Other countries in Latin America are still facing limitations from the local agencies to do a more technical analysis of registration submissions, which demand more time for direct interaction between the authorities and regulatory requesters.
ABG: What are some ideas of how formulators can work around these regulatory blocks?
FV: Formulators can work with experienced regional consultants and CRO, like Staphyt, who are working day-to-day in several regulatory systems for new products and for defense of established products.
The obtention of a product or substance registration requires many different skills. CROs remain more than ever a pull of expertise and knowledge that manufacturers and formulators can use to manage a part of their programs or a full registration dossier. They can customize services to help clients deal with peaks in workload, solve specific regulatory and technical problems, and build and submit a registration dossier.
ABG: How does your company help formulators?
FV: We have many clients who do not synthesize their own active ingredients, but source them from third parties, so effectively formulators. Nevertheless, this category covers a wide range of companies from large multinationals to smaller local or regional businesses that focus on both generic and innovative products, the latter being of importance particularly in the growing biocontrol segment. We help formulators, as we do any other client, by supporting the achievement of their business objectives by delivering to market new products in the most effective way, as well as defending their existing portfolio.
Internally, we have a panel of scientists, field agronomists and regulatory affairs experts who can fully manage all the work for our clients. In addition to the field and laboratory division in agrosciences, Staphyt has developed a strong regulatory affairs department. Today, more than 90 people in the regulatory department help our clients plan from the beginning the best strategy for each product and situation aiming for a quick, efficient, and robust registration process. Our local teams are capable of better assisting our clients with specifics for each region, implementing a very efficient follow up with the local authorities while giving them a clear view of their registration processes.
ABG: You have a global presence, with offices in several countries. Are there any regional challenges you face?
FV: At Staphyt, we have more than 500 people, more than 80 field trials stations and regulatory affairs offices. In Europe, our team manages more than 7,000 trials every year. Our global presence is one of our strengths and a real added value for our client as we have a local presence in all the key agricultural regions. We are the eyes and ears of our clients, managing trials in the field and in the laboratory, building protocol, knowing local agricultural practices as well as regulatory constraints and data requirements needed in a registration program.
Ten years ago, we faced the challenge to work and test biologicals. Over the past three years, the number of low-risk substances approved at the European level has doubled, the number of micro-organisms has also almost doubled, and the number of natural substances has tripled. In 2011, we answered this challenge and we set up a transversal team of experts dedicated to study biosolutions (BioTeam), because biosolutions are on the rise and require a distinct technical and regulatory approach.
ABG: With biologicals increasing in Brazil, how is your company responding to that development?
FV: We have a new presence in Brazil, which is a major step in our company development. Staphyt has a team of more than 50 people in the regulatory area in Brazil after acquisitions of Plurie and Leisor in 2022, making us the main regulatory services company in Brazil. We are in the final stages of acquiring a CRO, which will allow us to offer a large array of services in the area of research and development. Our goal is to cover the main agriculture areas of Brazil with a very strong team and research facilities able to support our clients’ needs.
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