Food safety consulting and research services | Biosafe

Contact our experts What happens after you contact 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.

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.

Regulatory Plan and Compliance Review

Understand your product's position within global regulatory frameworks and identify the key requirements for a comprehensive, high-quality dossier for safety evaluation.

Gap analysis

Gain insight into the regulatory prerequisites your product needs to meet and the steps required to ensure compliance.

Dossier preparation in the EU

Expertly compiled applications for the European Food Safety Authority's (EFSA) assessment of novel foods, food enzymes and feed additives.

GRAS Notice to FDA

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.

Literature reviews

Essential scientific literature reviews to bolster your product's safety assessment, including pathogenicity, allergenicity assessments, and historical safety records.

Dietary Exposure Analysis

Quantitative analysis to evaluate dietary exposure levels of substances in the food chain.

Supporting Scientific Publications

Assistance in drafting and publishing scientific papers, including introductions of new taxonomic units.

Novel Foods

Navigating the regulatory process for novel food products to achieve market authorisation.

Food Enzymes

Consulting on the regulatory and analytical aspects of authorizing food enzyme products.

Expert advice on regulatory and safety evaluations for feed additive products.

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.

Additional research Efficient
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.

Continuous Support with Authorities

Biosafe’s got your back, addressing post-submission queries.

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

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

Sirpa Kärenlampi

Scientific Director, Professor
sirpa.karenlampi@biosafe.fi

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