Regulatory Product approval with high quality, reduced processing time, cost and risk.
This is Schafer Scientific Solution’s commitment to you.
Let us take care about your regulatory issues while you focus on developing your product.
Distribute your product on the market without concerns about regulatory constraints. SSS offers our support to you to ensure a quick and cost effective registration process. We are here to help you.
Peace of mind: Everything is being done correctly
Who we are
The SSS team has technical and practical expertise from over 30 years of regulatory science industry experience in agricultural biotechnology. We are consultants who already know the best ways to generate your data with high quality and cost efficiency, as follows:
- Lowering the risk of: Test repetition, extra costs and delays in product approval.
- Increasing the chances of: Approval on the first submission, with no unnecessary steps.
We communicate openly, following global regulations on Good Laboratory Practice (GLP). With these guidelines, questions and obstacles in your process are minimized.
Because we know the agricultural production process, we understand what a registration delay can represent, loss of market share and the loss of millions of dollars by delaying the launch of your product.
SSS works with a balance between technology, and attention to three main points:
We care about… the regulatory requirements
Bureaucracies will seem trivial with our scientific work and communication perfectly aligned with the requirements of global regulatory agencies and organizations.
We care about… YOU
Your approval process will no longer be confusing and disorganized with customized solutions to your regulatory needs. This means that we serve from a simple report review to a complete dossier. We are always ready to serve with constant communication and advice.
We care about… your product
Successful products need lots of attention from the beginning until the end of the development cycle, we are there step by step.
SSS regulatory specialists are the best professionals in the market and will monitor and work daily to ensure your product approval, and that your submission data package is complete and robust.
With all requirements fulfilled, the final result is a complete data package and a clear and concise report/dossier.
Our services
Services provided
Digestibility Analysis
- Simulated gastric and intestinal digestion (SGF/SIF) and thermal stability assays.
Protein Production
- Design and produce proteins/peptides for regulatory studies in small or large scale capacity (milligram to gram amounts).
Bioinformatics
- Bioinformatics to assess allergen and toxin protein homology.
Statistical Analysis
- Statistical analysis for: NTO (non-target organisms), compositional analysis, agronomic performance and much more.
Regulatory Strategy
- Build regulatory strategy for protein characterization and expression analysis (ELISA and LC-MS/MS), including study design.
- Create regulatory strategies for local and global submissions.
Ecotox - Toxicological Studies
- Ecotox studies for different types of organisms, including terrestrial (Earthworms), aquatic (Daphnids), pollinators (Honey Bee), mice, etc.
- Study monitors to oversee the complete eco-tox package : dose/diet calculations, final report writing, and generation of the risk assessment package.
- Study monitors to oversee the complete insect bioassay package, from protein production to final report writing. Confirm protein activity and generate LD50’s.
- Plant equivalence studies to demonstrate heterologous protein equivalence.
Ecotox - Toxicological Studies
- Ecotox studies for different types of organisms, including terrestrial (Earthworms), aquatic (Daphnids), pollinators (Honey Bee), mice, etc.
- Study monitors to oversee the complete eco-tox package : dose/diet calculations, final report writing, and generation of the risk assessment package.
- Study monitors to oversee the complete insect bioassay package, from protein production to final report writing. Confirm protein activity and generate LD50’s
- Plant equivalence studies to demonstrate heterologous protein equivalence.
Training Offering
- Protein expression analysis using ELISA assay
- International Standard for Biotechnology Studies
- Detection Methods for GMOs (Genetically Modified Organisms)
- How to conduct regulated field trials
- Development of the ELISA assay
- Toxicology, Ecotoxicology and Risk Assessment
- Provide consultancy to establish GLP laboratories and equipment
Training Offering
- Protein expression analysis using ELISA assay
- International Standard for Biotechnology Studies
- Detection Methods for GMOs (Genetically Modified Organisms)
- How to conduct regulated field trials
- Development of the ELISA assay
- Toxicology, Ecotoxicology and Risk Assessment
- Provide consultancy to establish GLP laboratories and equipment
Due to the increase complexity of the market and regulatory organizations, SSS has put together the following services for you:
Large scale protein production
(amounts in grams) of proteins/peptides toxicological batches for use in ecotoxicological and mammalian studies
Strategy planning
We set up a local and global regulatory strategy for the deregulation of your product
Regulatory studies
We offer regulatory studies, study monitoring, in GLP or GLP-like, such as: ecotoxicological studies, digestibility, protein stability, bioinformatics, field studies for composition, expression and agronomics, among others
We help with your dossier
We offer to design and oversee the necessary regulatory studies, as well as the reports that will be used in your dossier; with quality that meet international standards
Who is the leadership that will take care of your project:
Ariane Schafer
President
Over 22 years of agricultural science experience (Monsanto, Dow AgroSciences, Covance and Eurofins ) providing expertise in project management, steering, cost estimating and financial information to ensure business objectives are achieved.
Study Director and Principal Investigator of studies critical to the registration of: Traits (GMO), pesticides and drugs / animal feed.
She has built and led successful teams for Biotechnology Regulatory Science in Brazil and Covance / Eurofins , USA.
Laboratory experience with analyzes of genetic purity of corn and soybeans, detection and quantification of proteins using methods such as isoenzyme, ELISA, SSR, SNP.
Barry Schafer
Vice-President
Thirty years of work in the area of biotechnology for agriculture, of which 22 years were dedicated to Regulatory sciences and 18 years in Research.
Global strategy leader for Dow AgroSciences and member of all regulatory strategy teams that successfully launched product lines for Herculex ®, WideStrike ®, PowerCore ®, SmartStax ® and enlist ®
Critical member of the Regulatory Science Leadership team that has developed budgets, growth strategies, capacity, skills and long-term plans for Dow AgroSciences for over a decade.
Identified and partnered with multiple external CROs to develop further capabilities to deliver regulatory data for global submission and deregulation of biotechnology products .
Represented Dow AgroSciences at ILSI and CLI. Currently represents SSS in industry groups to harmonize regulatory data for submission to global agencies.
We want to know your needs and help you reach them.
Location
- 880 Monon Green Blvd, Suite 101 Carmel IN 46032 - USA
- Schafer Scientific Solutions
- Schafer Scientific Solutions