Food safety consulting and research services
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Why us
With deep roots in industrial microbiology product safety assessment, Biosafe extends its consulting and regulatory support across global markets, focusing on the European Union, but assisting in expansion to the US and other regulatory areas.
We are the go-to experts for researchers, startups, and established companies seeking independent advice to navigate the complex regulatory environments for food and feed products. Our goal is to streamline your path to market, ensuring smooth progress in your ventures without unnecessary hindrances. By choosing to outsource to Biosafe, you significantly expedite the data collection, review, presentation, and decision-making processes.
Our work
Biosafe's consulting team is spearheaded by academic and regulatory experts renowned for their scientific acumen and valuable experience in EU scientific committees, panels, and beyond. We have insider knowledge on how companies work, which are developing new products. We also have a laboratory, where we do hands-on practical work around product development and testing.
Our professionals possess specialised expertise across various modern biology fields, offering a comprehensive suite of consulting services for food and feed safety.
See our
consulting
services
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Understand your product's position within global regulatory frameworks and identify the key requirements for a comprehensive, high-quality dossier for safety evaluation.
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Gain insight into the regulatory prerequisites your product needs to meet and the steps required to ensure compliance.
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Expertly compiled applications for the European Food Safety Authority's (EFSA) assessment of novel foods, food enzymes and feed additives.
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Guidance and support for preparing and submitting Generally Recognized As Safe (GRAS) notices to the U.S. Food and Drug Administration. We can also compile self-affirmed GRAS notices.
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Essential scientific literature reviews to bolster your product's safety assessment, including pathogenicity, allergenicity assessments, and historical safety records.
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Quantitative analysis to evaluate dietary exposure levels of substances in the food chain.
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Assistance in drafting and publishing scientific papers, including introductions of new taxonomic units.
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Your path to approved studies — what happens after you contact us?
What you do:
1.
Contact us
Take the first step and reach out to Biosafe.
What we do:
2.
Personalised Kick-off Meeting
Biosafe clarifies your objectives and expectations.
What you do:
3.
Accept the quote & provide background info
Tailor our services to your unique needs.
What we do:
4.
Tailored Gap Analysis (Optional)
Biosafe’s scientific review identifies potential data gaps. Works as the basis for additional research.
What you do:
5.
Review gap analysis
Provide feedback and inputs.
What we do:
6.
EFSA-standard Dossier Preparation
Biosafe ensures compliance with EFSA standards, queries EU officials if needed.
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Additional research Efficient
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Documentation Management
All your documents, neatly arranged and linked.
What you do:
7.
Review the dossier
Go over any dossier-related questions and risks with Biosafe.
What we do:
8.
End-to-end Dossier Submission
Biosafe aids in the ESFC platform submission.
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Continuous Support with Authorities
Biosafe’s got your back, addressing post-submission queries.
Contact us

Paula Pescador
Regulatory and Scientific Expert, PhD
+49 155 600 21 621
paula.pescador@biosafe.fi

Anne Ukkonen
Regulatory Manager, PhD
+358 40 5813 160
anne.ukkonen@biosafe.fi

Sirpa Kärenlampi
Scientific Director, Professor
sirpa.karenlampi@biosafe.fi
Book an appointment
for a consultation
Request a quote or ask for more information!
You can also make an appointment for a consultation.