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The regulatory part of SynTech Research offers comprehensive registration services for the biosolution and chemical industries in Europe, North Central and South America, Australia, and many African and Asian countries.
SynTech Regulatory, also known as GAB Consulting in Europe, is a company with over 25 years of experience in the chemical industry, providing services on an international scale. Founded in 1998 near Hamburg, Germany, GAB Consulting GmbH has grown to include a team of 50 regulatory scientists and documentation assistants, offering qualified and reliable regulatory services for agrochemicals, biopesticides, biocides, feed additives, animal pharmaceuticals, and chemicals (REACH) in compliance with the latest OECD and EU requirements.
Additionally, ECT Oekotoxicologie, a fellow SynTech Research Group company, plays a vital role in enhancing the regulatory services provided by SynTech Regulatory. The collaboration between these entities ensures that the company offers a robust and comprehensive suite of services to meet the diverse needs of the chemical industry.
SynTech Research Regulatory has offices in Stade and Heidelberg, Germany, Valencia, Spain, and staff in France, Italy, Ireland, Great Britain, Greece, Cyprus, Portugal, Hungary, and Poland. The company also maintains direct contacts with authorities in Austria, Belgium, Luxembourg, and the Netherlands and has established partnerships in the remaining European countries.
Globally, SynTech Regulatory is present in Delaware, USA, and Piracicaba, Brazil, with local contacts in Chile, Colombia, and Canada, and established partners in the emerging markets of CIS and other countries.
Our more than 100 regulatory scientists and documentation assistants are experts in the development, assessment and registration of new active ingredients and support and renewals of existing compounds, as well as for the respective formulations.
Our full range of services includes:
Attending global regulatory demands, as well the EU Zonal re-registration of products or (re-)approval of active substances – rely on our experts to develop and support to accomplish your business plan.
Our expertise spans from providing you with up-to-date information on your regulatory obligations and evaluation of data gaps, to the preparation, submission, and defence of complete dossiers for active substances and products according to Regulation (EC) No 1107/2009 and in compliance with national regulations.
We provide the full range of services related to the registration of agrochemicals in the EU following the criterion set out by Regulation (EC) No 1107/2009. In addition, we provide regulatory services for other geographies for new ais as well as generic substances, including Risk Assessment (Toxicological, Dietary, Occupational and Environmental). We assist you in building strategies and studies for complete dossiers for the active substances or products, as well as MRL dossiers, use extensions, minor uses, emergency uses, technical equivalences or other articles of the Reg (EC) No 1107/2009 and in compliance with national and international regulations in Europe and similarly for other geographies in North America, LATAM, Africa, or APAC.
In addition, to the preparation of dossiers for agrochemical active substances and products, we continually monitor regulatory changes to help you stay on top of new and developing requirements. Our wide range of services ensures your regulatory obligations are met in a timely and cost-effective manner.
Regulation should be considered from early stages to make sure the final product will fit to the legal framework according to the desired uses and geographies.
Biosolutions encompass all biological actives classified as Biostimulants and Biocontrol or Biopesticides, including Semiochemicals, natural extracts and microorganisms. These unconventional products require a customised regulatory approach. SynTech Research Regulatory delivers high quality dossiers according to product definition and classification under the right EU framework:
Biosolutions for abiotic stress and nutrition uses are regulated as biostimulants according to Regulation (EU) 2019/1009. Data requirements depend on the uses and composition of the product.
Biosolutions for biotic stress are regulated either as plant protection products under Regulation (EC) No 1107/2009 or as biocides under Regulation (EU) 528/2012 depending on the use of the product. In both systems, the active ingredients must be registered at the EU level before product registrations can be obtained. Data requirements for plant extracts and pheromones are the same as for chemicals, whereas separate ones exist for microorganisms.
Analogously attending also the different classifications and regulations at global level, for which we can build global registration strategies and use synergies to minimize registration costs across different countries.
Registration of biocidal products has become much more stringent – trust our team of experts to ensure smooth registration of your product.
In September 2013, the current Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) came into force. This regulation requires a more stringent analysis of biocides than previously.
Our experts are fully competent in the regulation and their expertise will ensure that you meet the new regulatory requirements. In addition to the preparation of dossiers for biocidal active substances and products, we constantly monitor the developments of the regulatory affairs assuring an exhaustive fulfilment of your obligations as a producer. In borderline cases our strong experience with active substances and related products from various categories enables us to advise you which regulatory framework is applicable and how regulatory compliance can be achieved.
A step forward in the fertilizing products industry was given since the publication of Regulation (EU) 2019/1009, which entered into force in July 2019, and is fully applicable since July 2022.
Fertilizing products, which include fertilizers, liming materials, soil improvers, growing media, inhibitors and plant biostimulants, can now be placed on the EU market by means of a certification valid for the 27 Member States.
In the EU market, European regulation co-exists with national regulations, and SynTech Research Regulatory experts have long expertise in registration both at national level as at EU level. We provide a full service to our clients, including the discussion for determining the best strategy for placing a single product on the market, according to the client’s needs and capacities.
We also cover registrations in Africa, Asia, America and Oceania, where we have many cases of success in registration of fertilizing products.
Products are classified according to their function and their composition, which will determine the registration pathway. Requirements for biostimulants are more stringent than for other fertilising products, especially if they include microorganisms in their composition. At SynTech Regulatory, we will advise you from the early stages of formulation to the final placing of the product on the market.
Our team of pharmaceutical experts at SynTech Research Regulatory compiles dossiers for the environmental risk assessment of human as well as veterinary medicines. We are familiar with all parts and tiers of the environmental risk assessment of pharmaceuticals. Based on our experience in national and international research projects, we can provide scientific expert advice particularly in complex cases, higher tier requirements and risk management options.
SynTech Regulatory supports your company during the pharmaceutical registration procedure by providing the following services:
Our REACH experts are specialised in the area of ecotoxicology, environmental fate, and behaviour as well as physico-chemical properties of industrial chemicals. Additional areas are covered through the well-established and reliable co-operation with partners.
Prior to the implementation of REACH, we gained experience with industrial chemicals through the compilation and successful submission of more than 30 SIDS dossiers (screening information data sets) for high production volume (HPV) chemicals in co-operation with companies, consortia, and competent authorities. Since 2007, we have been involved in the registration of more than 300 substances. Thanks to our engagement in research projects, we are familiar with specific data requirements related to substances of very high concern (SVHC), persistent, bioaccumulative and toxic (PBT) substances, and endocrine disruptors.
SynTech Regulatory supports companies together during the entire REACH process by offering the following services:
For further information please email: info@syntechresearch.com
