SynTech Research Group - A Global Leader in BioSolutions Industry Regulatory Services

Date:08-20-2024

SynTech Research Group (SynTech) is a company built as a science-based R&D service provider specialized in conducting Agricultural Research and Product Development (End-To-End) services for Crop Protection, Seeds/Traits and BioSolutions industries. 

The company was established by merging best in class Ag CROs in their field of expertise (Field Experiments, Laboratory (Analytical, Biology & Ecotox) and Regulatory Affairs). This was combined with an experienced management team who worked in Ag multinationals before creating the company. It is now a Group of integrated companies that can cover the complete testing cycle from laboratory to full registration in muti-environmental conditions, globally. 

Over the past three decades, SynTech has developed testing methods (laboratory, greenhouse, and field) according to the latest scientific standard operation procedures which have provided highest quality evaluation and predictability of products performance. Showing the best performance for BioSolutions Agricultural inputs such as Biofertilizers, Biostimulants, Biocontrol and Biopesticides products is a challenge SynTech scientists have been successfully addressing globally for more than 25 years. 

SynTech supports its clients throughout the complete development cycle of traditional and biological products, preparing the protocols from early-stage screening (Laboratory, Greenhouse and Microplot) to full field testing and complete Registration packages. 

Regulatory Affairs Offering

Due to consumer demand and consequent changes in regulations at the global level, more regulatory support is required to register and defend Crop Protection products including BioSolutions and specialty Fertilizers. Regulations varying across all regions, countries and states, and each location has its own requirements. SynTech Global Regulatory Team can provide global Data Gap Analysis reports to make sure the performed studies are acceptable between geographies in order to avoid repeating studies to comply with additional requirements when the targets are multiple countries. Furthermore, costs optimization across crops, pests or countries is also carefully considered. SynTech Regulatory Teams interact regularly with local Authorities to defend registrations and are able to recommend the most adequate higher Tier studies when needed to overcome the regulatory hurdles.

In order to be in compliance with local regulatory guidelines, a clear understanding of the up-to-date data requirements is essential for designing an accurate and effective registration roadmap which is the key crucial single parameter for a successful approval of any new and or existing products. This not only reduces the cost and timetable of any registration process, but also accelerates the client’s products faster to the market.

SynTech Regulatory Teams are specialized in preparing and simplifying such roadmap to achieve the approval of your products’ registration in the shortest possible time cycle possible. This is the top priority Commitment of SynTech to its clients. 

Over the past four years, a highly quality trained global in-house team has been created (>100 staff), plus a number of selected long-term associates around the world. SynTech Regulatory centers are located near Hamburg & Heidlberg/Germany and Valencia/Spain (Global BioSolutions - Center of Excellence) for EU, Hockessin/USA for North America, Piracicaba/Brazil and Medellin/Colombia for Latin America and Manila/Philippines for Asia regions. In addition, there are team members working remotely in over 40 countries to ensure direct access to the local authorities. 

Our Service Offering Includes:

• Drafting roadmap for dossier preparation for registration of new products at State, Country, Regional and Global levels.

• Drafting roadmap for dossier preparation for existing products including new formulations, label extension at State, Country, Regional and Global levels.

• Reviewing and analyzing the regulatory packages, identifying and fixing any potential gaps and defending such dossiers until successfully registered.

• Risk assessment services including ecotoxicology, environmental fate, and operator exposure modelling.

• Full support of regulatory packages after they are registered during the life of the products - Stewardship.

• Holding the registration packages for selected countries as long as necessary.

The Future Strategy

Regulatory Affairs is one the three key pillars of SynTech with strong market growth. Our company is committed to invest in this offering to serve its clients globally. BioSolutions service offering has already represented >50% of SynTech Regulatory turnover. Going forward, significant growth is occurring in NAM and LAM regions in the short-term, given their more BioSolutions favorable legislations. The group is rapidly expanding in-house expertise to have complete global services. Having competent in-house global expertise enhances the prediction of successful registration outcome. 

Visit our website: https://syntechresearch.com for more information.

If you have any question on this article or SynTech's services, please contact us at info@syntechresearch.com.

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This article was originally published in AgroPages magazine 2024 Biologicals Special.