23 Rue De Moeuvres
62860-Inchy En Artois, France
Tel: 00 33 3 21 21 45 21
Fax: 00 33 3 21 21 45 19
Contact: Fanny Vanel (Marketing Manager)
Staphyt Regulatory is a consulting company specializing in chemical regulatory affairs. Operating in the agrochemicals, biologicals, biocides and general chemical sectors, our mission is to keep manufacturers informed about the regulations that apply to their businesses. We help our clients to achieve smooth entry to the market of their substances and products, in compliance with national and European regulations.
Our expertise covers all areas related to chemical risk assessment: Physico-chemistry, analysis, toxicology, ecotoxicology, residues, biological efficacy, etc. Our team brings together the expertise of scientific and regulatory experts, and we can also rely on a network of external consultants throughout Europe.
Plant Protection & Nutrition expertise:
We can assist you in all regulatory procedures required to obtain active substance approval and/or product authorisation for both chemical and biological products (EC 1107/2009, EC 2003/2003,...).
Benefits of working with us:
Both agronomic experimentation and regulatory affairs expertise gathered in one service company! We offer you real added value by taking charge of your projects from the earliest stage all the way through to registration.
Kerona Scientific Ltd
30 Thomas Hand Street
+353 1 849 5284
Kerona Scientific is an award winning European regulatory consultancy, headquartered in Ireland with offices also in Southern Europe (Spain).
We specialise in providing quality and timely regulatory services to our clients, who include some of the leading names in the proprietary and generic plant protection, biocides, fertilisers, plant biostimulants and biopesticide industries.
Kerona Scientific provides strategic regulatory advice to clients on the project management of new product introductions, from concept through to marketing as well as optimization of existing portfolios.
Working with chemical, microbial and low risk active substances, our services include but are not limited to:
Comprehensive data gap analysis, with costs and timescales of any required studies
Study commissioning and monitoring, from first request for quotations to review of protocols, draft reports and final reports
Task force management
Preparation of full zonal dRR dossiers and national addenda including all summaries evaluation and risk assessment
Project Management of renewal of active substances at EU level (AIR programmes)
Preparation of biological assessment dossiers (BAD)
Data matching evaluations for AIR projects
Technical equivalence applications for new or secondary sources
Preparation of product SDS
Classification and labelling advice
Our clients benefit from our experience amassed over 26 years and spanning all areas from plant protection products (Regulation (EC) No 1107/2009) to biocides (Regulation EU (No) 528/2012), fertilisers, plant biostimulants and agronomic additives at European and Member State level. Our native English, German, Spanish, Lithuanian, Polish and Arabic speakers can assist with registrations across the Middle Eastern and all European regions.
Kerona Scientific Ltd
Headquarters: 30 Thomas Hand Street
Skerries, Co Dublin K34 RX24, Ireland.
Tel: +353 1 849 5284
Kerona Scientific Ltd
Paseo de la Castellana, 179
C.P. 28046, Madrid, España
Tel: +34 912 865667
Charles River is a global provider of agrochemical studies and services, helping customers around the world meet current and evolving regulatory requirements. With multidisciplinary scientific expertise and facilities throughout North America and Europe, we are able to design custom programs to address the unique needs of our clients, regardless of their geographic location.
Full integration of in-life phases with our in-house analytics provides our clients with the confidence of knowing their studies will be done right, on time. For more than 40 years, our customers have trusted Charles River to provide dependable communication, on-time accurate study data and optimized study designs that incorporate offerings from our broad range of services.
Our extensive portfolio includes:
Physicochemical, 5-batch analysis, product characterisation, stability testing
Acute through chronic exposure, immunotoxicity, neurotoxicity, genetic and reproductive toxicology
Skin absorption and metabolism, skin irritation and corrosivity studies, eye irritation
Residue, efficacy, human exposure, crop tolerance/selectivity, variety/variety tolerance, home and garden, glasshouse, forestry, soil dissipation and accumulation studies
Ready and inherent biodegradation, aerobic and anaerobic degradation, soil adsorption/desorption, hydrolytic and photolytic stability, soil dissipation and accumulation
Fish (acute, chronic, reproductive and developmental toxicology), fish bioaccumulation and metabolism, terrestrial and aquatic invertebrates, algae, aquatic plants, soil microorganisms
Plant metabolism, livestock metabolism and feeding studies, crop and residue field trials, processing studies, succeeding crops
Endocrine disruptor studies, formulation support
Our ongoing investment in new facilities and equipment helps us maintain our position at the leading edge of contract research.
Custom-designed ecotoxicology facilities
28,000 square meters of modern, open-plan laboratories
On-site glasshouse facilities
GLP- and GEP-accredited field bases throughout northern & southern Europe
50 hectares of grassland at our research farm near Edinburgh
LKC Switzerland Ltd
LKC Switzerland Ltd
P.O. Box 167
+41 61 906 85 00
+41 61 906 85 09
LKC provides clients with independent regulatory experience and advice for cost effective global registration of their specialty chemical products.
Companies benefit with their strategic development which includes established contacts with Regulating Authorities, contracting and monitoring studies including higher tier studies;interpreting the impact of findings; conducting risk assessments, submitting regulatory dossiers including CADDYxml, IUCLID and METI formats and support post submission.
As a GLP certified facility LKC can conduct multi-site supervised residue and operator exposure studies. With a global network of regulatory advisors with a focus on major regions of agronomic importance, LKC can offer clients global support.
Contact LKC for scientific and practical solutions to your regulatory challenges.
Staphyt incorporating APC
APC is a leading regulatory and development consultancy, providing high quality solutions to its customers in the areas of Plant Protection, Biocide, REACH and Veterinary products. Our aim is to be our clients’ preferred global partner. APC’s worldwide team of experts provide regulatory services to the Agrochemical (Reg. 1107/2009), Biocidal(Dir. 98/8/EC & Reg. 528/2012) and Chemical (REACH Reg. 1907/2006) industries.
Our consultancy has 3 main strengths:
Scientific: Chemists, agronomists, toxicologists & environmental experts.
Regulatory: Each member of our worldwide team has extensive knowledge and expertise in their market sector and of country specific and regional regulatory requirements.
Strategic & project managers: Business experts with hands-on experience.
Compliance Services International (CSI)
Since 1988, CSI has been specialising in regulatory and scientific consultation to the crop protection and allied industries.
CSI’s services include agrochemical, biopesticide/biostimulant, biocide, chemical and cosmetic registration, hazard assessment (including QSAR, GHS CLP and Endocrine Disruptor potential), exposure assessment (including modelling), risk assessment (including for human and veterinary medicines, and relating to endangered species), study monitoring, data compensation evaluations, and M&A regulatory due diligence.In the EU, CSI can assist with Member State (including Mutual Recognition) or pan-EU compliance with key Regulations, e.g. EU 1107/2009 (Plant Protection), EU 528/2012 (Biocides) and EU 1907/2006 (REACH). CSI can also provide support for global regulatory strategies (including under the OECD Joint Review Process for Pesticides).
EBRC services include full regulatory support for plant protection products, biocides and industrial chemicals (REACH). Assistance is provided for plant protection product registrations according to all EU national legislations and EU requirements, including biological dossiers, complex exposure/risk assessments and computer modelling of environmental fate behaviour.
Additional speciality services are available for non-crop uses of active substances, but also for niche products (such as rodenticides) and inorganic compounds. Dossier compilation is available in CADDY as well as IUCLID format. Task force management, project coordination and scientific monitoring of experimental investigations complete this package of services.
ERM (Environmental Resources Management)
Regulatory specialists guiding you through the registration complexities of the agrochemical, biocide and chemical industries. Our team of European regulatory experts including the acquired team at JSC International can extend support globally through ERM’s product services offering. Environmental Resources Management (ERM) is one of the world’s leading providers of EHS and sustainability management, technical consulting and IT implementation services, with considerable experience in providing global product stewardship services.
Polgar ACRO Kft (Russia, Ukraine, Kazakhstan, Moldova, Belarus)
Polgar ACRO Kft
(Russia, Ukraine, Kazakhstan, Moldova, Belarus)
Szépvölgyi út 147
+36-70-315 77 66
+36-1-437 03 52
Polgar ACRO delivers wide range of regulatory services in CIS (Russia, Ukraine, Kazakhstan, Moldova, Belarus) including comprehensive support for registration of pesticides, biocides, bio pesticides, microbials, fertilizers, pest control agents, surfactants and other products. Our experienced regulatory affairs specialists are ready to provide professional assistance in the dossier preparation, study management, organization of trials and communication with authorities.
Apart from that, Polgar ACRO offers organization of demo-trials and public hearings, assistance in patent issues and registration of brand names.
Scientific Consulting Company
SCC is a privately owned and independent regulatory consulting company. Since 1989, we have been supporting our international customers with cost-efficient solutions for their scientific and regulatory needs. Our expertise extends over a broad range of areas, including agrochemicals and biorationals, chemicals and biocides, feed and food additives, food contact materials, cosmetics and consumer products as well as pharma pre-clinical.
Our long-standing expertise includes defence of more than 90 chemical and biological active substances under Directive 91/414/EEC and Regulation 1107/2009, compilation of plant protection product dossiers (> 500), filing of more than 600 LEAD dossiers for phase-in and non-phase-in substances, submission and defence of numerous dossiers for biocidal active substances and products, preparation of more than 50 reauthorisation dossiers for feed additives as well as management of more than 30 task forces.
SCC stands for meeting every single deadline: we are the experts for regulatory challenges – large and small. More than 130 highly skilled, team-focused employees, mostly academics, form the backbone of our company.
SCC has 2 offices in Germany – the headquarters in Bad Kreuznach and an office in Berlin, and runs SCC Japan K.K. in Tokyo.
We care for your success.
1 place des Alpes
+41 22 739 91 11
+41 22 739 98 00
Contact: Olivier Coppey
Tel: +41 22 739 93 77
SGS Seed and Crop Services provides a global network of field stations and laboratories for client’s product development and registration programmes in Europe, North America, Latin America and Asia-Pacific.
Our experienced interdisciplinary team of agronomists, biologists, chemists, food technologists and geochemists can conduct field trials and laboratory studies to support the screening, development and registration of agricultural and horticultural chemicals, biopesticides, fertilizers and new plant varieties and seeds (including GMO).
With many years of experience in the field of R&D, analytical chemistry, regulatory testing, consulting and project management, SGS conducts registration studies, such as efficacy, residue, operator exposure, consumer safety, environmental fate and the behaviour of pesticides as well as ecotox testing.
The studies are based on international guidelines, including EPPO, OECD, EPA and SETAC and in compliance with GLP (Good Laboratory practice) or GEP (Good Efficacy Testing). SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognised as the global benchmark for quality and integrity. With more than 70'000 employees, SGS operates a network of over 1'350 offices and laboratories around the world.
Agrooh Bioscience Translations
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Multilingual translations and many other linguistic services in the Agribusiness Food sectors (Agrochemicals, biocides, seeds, fertilisers, food processing, biotechnology, plant breeding, animal health, genomics).
We have worked extensively for these industries for 18 years. Services are available in over 40 languages. Our translators all have a scientific background (agronomy, chemicals, veterinary etc.) Services: translation, interpreting, video transcription, brand screening, website & other IT tool localization, dtp. Regulatory – CLP Reach, SDS, scientific articles, product labels & brochures, market research questionnaires, promotional material.
Ecotox Services International
Ecotox Services International
2 Chaplin Drive
Lane Cove, Sydney
0061 2 9420 9481
Located in Australia, Ecotox services International (ESI) is able to offer honey bee studies off season, in addition to providing the standard suite of ecotoxicity studies. Ecotox Services International (ESI) is the sister company of Ecotox Services Australasia (ESA) formed in 2001.
ESI was formed specifically to provide contract ecotoxicity testing services for chemicals and products for international regulatory assessment purposes in compliance with the OECD Principles of Good Laboratory Practice (GLP). A wide range of acute and chronic ecotoxicity tests are available, run with aquatic and terrestrial organisms.
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