Regulatory services by people who care
Latest News
2024-09-01
Welcome Gianni!
We are delighted to announce that Gianpiero “Gianni” Gueli Alletti has joined us as our Lead Regulatory Affairs Manager for plant protection products. With extensive experience in the approval and re-approval of active substances and product registrations across Europe and the United States, Gianni is a fantastic addition to our Vali family. He will be stepping into the role previously held by Sascha Otto. Sascha will now be dedicating his expertise exclusively to the area of ecotoxicology.
Gianni began his journey at the Julius Kühn-Institut, part of Germany’s federal biocontrol institute, as a student and PhD researcher. He has since developed regulatory expertise at GAB, APIS, knoell, and Aphea Bio. Passionate about exploring and promoting biocontrol in the EU and US, Gianni is dedicated to driving innovation in sustainable solutions.
Bringing a unique perspective and a deep passion for biocontrol, we are excited to see the positive impact Gianni will have on our projects and clients. Above all, he is a great listener, always open to creative problem-solving and navigating regulatory hurdles.
Please join us in congratulating Gianni on this new journey and wishing Sascha all the best in their focused endeavors!
2024-03-04
Dublin Biocides Symposium 2024
Kerona is holding their annual Biocides Symposium on March 20th and 21st, 2024.
Kerstin Schrade will speak on Day 2 about National Restrictions in self-service for Biocides.
More information about this event and registration can be found here.
We look forward to this event and your participation.
2023-11-01
Welcome Beatrice!
Vali welcomes our new colleague Beatrice Mah. Beatrice is our new Junior Scientific Expert for Ecotoxicology with a Bachelor of Science in Biochemistry.
Beatrice is currently a master student studying Ecotoxicology at RPTU Kaiserslautern-Landau.
She has experience in regulatory affairs, quality management system audit and documentation of product dossiers.
We are pleased that Beatrice is joining the Vali team and wish her a good start.
2023-04-21
Tutorial for biocidal products (in German)
Chem-Academy is providing an online training for biocidal products (in German) on May 8th and 9th, 2023 .
Kerstin Schrade and Dr. Thore Wendler from Vali are two of the seminar leaders.
More information about this event and registration can be found here.
We look forward to this event and your participation.
2023-03-28
Vali - New member of IBMA Germany and Spain!
We proudly announce our membership in the International Biocontrol Manufacturers Association (IBMA) Germany and Spain.
IBMA provides a platform for its members to express and share their views to further shape one common positioning of the biocontrol technologies industry towards institutional actors, policy makers, media and the public. Their goal is to bring green innovative and effective technologies to the market for sustainable agriculture.
Vali is looking forward to the cooperation within this network. With our experienced team and insight knowledge we will be a strong and valuable partner, to help achieve this goal.
2023-03-17
Welcome Tanja!
Vali welcomes our new colleague Tanja Gaber. Tanja is our new key account manager for business development with a degree in biology.
Tanja is an experienced communications specialist with a background in psychology. Before starting at Vali, she worked in the communications department of a pharmaceutical company, where she gained experience on the registration of vaccines. She spent the last six years in a life science company focused on bioscience and material characterization.
We are pleased that Tanja is joining the Vali team and wish her a good start.
2022-12-21
Merry Christmas and a Happy New Year!
Vali wishes all clients, employees, and friends a merry Christmas full of love, joy and peace and a prosperous, successful New Year.
2022-09-06
Welcome Jesica!
Vali welcomes our new colleague Jesica Fabro. Jesica is our new regulatory affairs manager for biocontrol solutions with a MSc in Horticultural Sciences.
Jesica is an experienced biotechnologist with a background in molecular biology and plant biotechnology. Before starting at Vali, she worked in the regulatory affairs department of an Austrian plant protection products company for three years, where she gained experience on the registration of microbial active substances and plant protection products.
We are pleased that Jescia is joining the Vali team and wish her a good start.
2022-01-17
Poison Center Notifications (PCNs)
Poison center notifications (PCNs) can be sent via the ECHA Submission portal to the appointed body of Belgium (also responsible for the receiving notifications for Luxembourg), now.
If you need any help with you PCN, please check Vali services for Poison Center Notifications.
2021-12-22
Mitigation of bottlenecks in ecotoxicological EDC testing capacities
Dr. Viktoria Urban (Regulatory Scientific Expert Ecotoxicology at Vali) was one of the speakers at the virtual conference Biocides Europe 2021.
Her presentation “Mitigation of bottlenecks in ecotoxicological EDC testing capacities“ dealt with capacity issues and challenges of labs for ecotoxicological EDC testing as well as mitigation options for potential bottlenecks:
Since 2018 there are scientific criteria for ED applicable for biocides and pesticides. After three years of ED testing in European labs, most labs established level 3 studies, are able to run fish level 4 studies (which are rarely conducted), but are not prepared for fish level 5 and frog level 4 studies. To get a study done, expect 2 years of waiting time.
Challenges in the test capacity contain space and equipment of the laboratories. More diluter systems, water capacity and space are often needed, but not every lab can afford this.
There are also challenges concerning test organisms: Fatheads are not available in Europe and are shipped from only a few suppliers in US. A high number of animals is needed and the time to reproduction stage is 4 to 6 months. So, in house-breeding and large breeding capacities are needed.
Another challenge is the fish health: Pathogens in fish are common. So, there is a high risk with each import. Regular controls of fish health are necessary.
Further challenges lie in long-term studies, because there is no data requirement in EU from before 2018. So, only little experience is available. There are also high costs for implementation and lab capacities are already booked up, which complicates establishing long-term studies.
To avoid bottlenecks it is important to start early with study preparation, evaluate available data and tailor an appropriate test strategy. If data and substance properties allow, the use of short embryo-based tests might be helpful. To avoid repetition of testing, ensuring health of test organisms and experience of histopathological partner labs are important. Increasing output of studies by setting appropriate test concentrations and considering inclusion of liver histopathology to check for systemic toxicity are an approach. A faster update and development of guidelines as well as realistic validity criteria for the labs in the guidelines could help to avoid bottlenecks.
If you need any help or advise for EDC testing, please contact our experts at Vali. Further information about our services for evaluation of potential endocrine disrupting properties can be found here.
2021-10-06
Problems with IUCLIDs? Check our services!
Vali offers services on IUCLIDs like:
- preparation of all relevant dossier parts in IUCLID format,
- transfer of existing dossiers in IUCLID format,
- stand alone study summaries,
- general support on several IUCLID topics
- and much more.
For more information, please click here!
2021-07-13
Do you know KISAR BIOSOLUTIONS?
Vali is co-founder and main contact of KISAR BIOSOLUTIONS group which is composed by four companies:
Vali Consulting (active ingredients / products registration),
ibacon (GLP services: ecotoxicology, phys-chem, environmental fate),
Clever Bioscience (development from active to formulated products),
GMW Bioscience (EU CRO GLP / GEP field trials, GH under CCC).
KISAR offers smart innovative technologies which improve food quality. These technologies ensure food security & public health and are environmentally friendly.
KISARs activities include research, development and registration of biopesticides, biostimulants and hybrid PPP formulations.
The projects can be managed from their idealization to market authorization, passing through important processes such as: discovery, development up to industrial process for actives and formulations, efficacy trials, dossier preparation and submission.
A more comprehensive information on KISAR is provided under:
www.kisarbiosolutions.com and https://www.linkedin.com/company/kisar-biosolutions
For further information don’t hesitate to contact Dr. Saúl Molina-Herrera.
2021-05-10
Welcome Viktoria!
Vali welcomes our new colleague Dr. Viktoria Urban. Viktoria is our new regulatory scientific expert on ecotoxicology and endocrine disruptors with a PhD in natural sciences.
Viktoria is an experienced ecotoxicologist with a background in aquatic ecotoxicology, molecular ecotoxicology and endocrine disrupting properties. Before starting at Vali, she has worked in the aquatic department of a contract research organisation where she was the team leader for fish and endocrine testing.
Furthermore she has worked several years in research with the focus on biomarker identification for endocrine disruption in fish.
We are pleased that Viktoria is joining the Vali team and wish her a good start.
2021-03-16
Biocides in UK/Resubmission for ongoing applications
With regard to Brexit the United Kingdom has implemented its own system to regulate biocides.
As a consequence, as of 1 January 2021 UK has no longer access to EU IT systems such as R4BP3, thus, it is no longer posssible for UK authorities to access ongoing applications in the EU and the respective data sets.
If you want to know more details, click here.
2021-03-08
Welcome Ana!
Vali welcomes our new colleague Dr. Ana María García Carril. Ana is our new regulatory scientific expert on physical /
chemical properties and analytics with a PhD in Chemistry.
Ana is an experienced organic chemist with a background in synthesis of organic molecules, molecular recognition and combinatorial chemistry. Before joining Vali, Ana worked as a regulatory expert for ten years for the Spanish Authorities (INIA) in the registration of plant protection products at EU level and for the Spanish Agency of Medicines in the registration of veterinary medicines.
Furthermore, Ana worked for a consultancy for nearly 2 years where she gained experience with the registration of Biological Plant Protection Products.
We are pleased that Ana is joining the Vali team and wish her a good start.