Biosafety · Occupational Safety & Health · Quality Management

Your external back office for your laboratory

Operational excellence with a focus on quality. Based in Berlin, we support small and medium-sized enterprises across all federal states of Germany — from the concept phase through operation to decommissioning.

Biosafety in Genetic Engineering External Project Manager & Biosafety Officer per §28 / §29 GenTSV — officially confirmed in 11 federal states.

Occupational Safety & Health Sicherheitsfachkraft (Sifa 3.0) per §5 ASiG & DGUV V2 — a preventive approach that motivates your team.

Quality Management GLP, GCLP, GCP, ISO alignment, sponsor oversight, interim COO or site manager, external QA back-up.

Contact us Explore services

Made in Berlin · Browser App Family

SafetyCampusTraining apps and working tools that run in every browser

Scalable onboarding and briefing apps for laboratories and offices — GDPR-compliant, trilingual (EN / DE / FR), one-time purchase with no recurring licence fees. Born of day-to-day consulting work in German laboratories and genetic engineering facilities.

GDPR-compliant · no external servers required
Trilingual EN / DE / FR
One-time purchase — no licence fees

Explore the App Family

We share the same vision

As your partner from the very start, we support your internal processes throughout the entire lifecycle of your facility — from the concept phase, through the project and operational phases, to decommissioning.

This also makes coordination with the competent authorities easier.

We favour a collaborative consulting style, bringing all key stakeholders around the same table for better decisions.

SDS Generator

Safety Data Sheets · REACH & CLP compliant

Create, maintain and export Safety Data Sheets that align with REACH (Annex II) and CLP requirements — without the usual template gymnastics.

What you get

AI-assisted PDF import of existing SDS documents
eSDScom XML export for downstream systems
UFI-code generation and validation
CLP mixture calculator — fully traceable and documented
GHS, H and P statements, ASR A1.3 pictograms and more than 5,000 EuPhraC phrases, maintained centrally
TRGS 400 plausibility check with audit trail, SHA-256 hash and PDF report
BAuA’s Simple Measures Concept for Hazardous Substances (EMKG)
NEW: Get a 14-day trial licence for the full version

Find out more 👉

Good Laboratory Practice (GLP)

Good Laboratory Practice · ChemG Annex 1 · OECD GLP

An introduction to the principles of Good Laboratory Practice for your (future) GLP test facility — developed by a GLP quality assurance professional and former head of a GLP test facility.

What you get

Fully covers Annex 1 ChemG and the OECD Principles of GLP — plus computerised systems
7 core modules: legal basis, organisation & roles, facilities & archives, equipment, test items, study plan & report, QA & SOPs
6 optional deep dives: data integrity (OECD No. 22), computerised systems (No. 17 + cloud supplement), IT security (No. 25), multi-site studies, OECD Test Guidelines & MAD, GLP monitoring in Germany
Multiple-choice quiz with feedback — PDF certificate of participation with digital signature
German and English — French in preparation
No user accounts, no server storage — GDPR-compliant, one-time purchase

Find out more 👉

Genetic Engineering S2

Genetic Engineering Briefing · ArbSchG §5 / GenTSV §17

Digital safety level 2 briefing based on the current GenTG and GenTSV — ideal for future operators and project managers.

What you get

11 core learning modules
22 interactive comprehension questions
5 optional add-on modules (plants, ZKBS, bioreactors, ADR transport, teaching)
PDF confirmation of attendance with digital signature
Trilingual — EN / DE / FR, switch at any time
One licence and off you go – no annual fees, unlike cloud-based e-learning providers

Find out more 👉

Biosafety & Biosecurity

Coming 2027 · BioStoffV · TRBA 100 / 400 / 405

Instruction of laboratory staff working with biological agents in BSL-1 and BSL-2 environments — helps you fulfil §14 BioStoffV in three languages.

What to expect

Content based on BioStoffV, TRBA 100 (November 2025 release) and TRBA 400 / 405
Learning modules on risk groups, containment, PPE and disinfection
Interactive questions with digital signature and PDF certificate
Optional add-on modules for BSL-2 exposure assessment
DE EN FR — switch languages at any time
Same delivery model as the other SafetyCampus apps — browser-based, GDPR-compliant, one-time purchase

Reserve early access 👉

Our Services & Products · Quick Access

Services and products for your organisation An independent outside view builds trust — your staff may come and go, but we stay by your side.

Biosafety in Genetic Engineering

External Project Manager (§28 GenTSV) · Biosafety Officer (§29 GenTSV)

Operating a genetic engineering facility in Germany — or planning to set one up? Appoint us as your external Project Manager or Biosafety Officer (Beauftragter für Biologische Sicherheit, BBS) and keep your facility compliant from the concept phase to decommissioning.

What we do for you

Appointment as external Biosafety Officer per §29 GenTSV or Project Manager per §28 GenTSV
Notification, registration and approval documents for S1 and S2 facilities (§§ 8, 9, 10 GenTG)
LAG application forms in an editable Word version — insert text, images and flowcharts directly
Risk assessments, SOPs and operating instructions for genetic engineering work
Liaison with the competent authority in your federal state
Service level agreement with clearly defined responsibilities and a confidentiality agreement
Biosafety officer for schools running GMO experiments

Officially confirmed in these federal states

Baden-Württemberg · Bayern · Berlin · Brandenburg · Bremen · Hamburg · Hessen · Mecklenburg-Vorpommern · Niedersachsen · Nordrhein-Westfalen · Thüringen · Coming soon: Rheinland-Pfalz

Biosafety Officer services Request a quote

Consulting & Occupational Safety

Regulatory consulting · External safety specialist (Sifa 3.0)

We turn German regulatory requirements into documents and processes that work in everyday practice — in German and English, ready for your teams and the authorities.

Regulatory consulting

Standard operating procedures, policies and manuals
Quality records such as change control and CAPA
Process maps, organisation charts and flowcharts
Operating instructions for biological agents, hazardous substances and equipment
Safety data sheets per REACH Annex II, prepared by a competent person
Sample imports from outside the EU and permits for animal by-products per Regulation (EC) 1069/2009
German forms for the competent authorities — completed and coordinated for you

Occupational safety & health

Appointment as external safety specialist per §5 ASiG and DGUV Regulation 2
Risk assessments, including psychosocial risks
Site inspections and occupational safety committee meetings
Coordination with your accident insurer (Berufsgenossenschaft) and the competent authority
Coordination of external contractors on your premises

Consulting services Request a quote

SafetyCampus Browser App Family

Scalable in-browser training modules and working tools

SafetyCampus is our scalable family of browser-based training modules and working tools for laboratories and production facilities.

Training modules deliver legally compliant, trilingual (DE/EN/FR) instructions on biosafety, genetic engineering and hazardous substances — with multiple-choice tests and confirmation of participation.

Apps are practical tools that streamline your daily work: from compliant safety data sheets (SDS) to long-term retention in electronic archives.

Find out more

Remote Training & In-House Seminars

Training and instruction · online or on site

Setting up a new facility, onboarding a new team or preparing for an inspection? We tailor the content to your needs and deliver it online or on site. Every participant receives a confirmation of attendance listing the training content.

Occupational safety & biosafety

Approvals you need to run a life-science facility in Germany
Mandatory instructions per §12 ArbSchG, §14 BioStoffV and §17 GenTSV
Hazardous substances and safety data sheets in the laboratory
Your own topic — on request

Quality management

OECD Principles of Good Laboratory Practice (GLP) and GLP special topics
Blended learning: self-study with the SafetyCampus GLP Training app plus a live Q&A session
Computerised systems life-cycle management (GLP / GCP / GAMP 5®)
Good Clinical Laboratory Practice (GCLP) for laboratories processing clinical-trial samples
Sponsor responsibilities and investigator oversight under ICH GCP E6(R3)

Training & seminars Request a seminar

Quality Management & Quality Assurance

GLP · GCLP · GCP · Interim site management

Bring us into your organisation as interim site manager or chief operating officer (COO), as short-term QA backup or as permanent external QA support. Study sponsors without their own audit capacity can engage us for site qualifications.

How we support you

GLP: align your QA programme with the OECD Principles and prepare for inspections — see our GLP leaflet
GCLP: add value to your ISO-aligned QA programme for clinical-trial samples — see our GCLP leaflet
GCP: QA for study sites and sponsor-side QA programmes compliant with ICH GCP E6(R3)
Audits: site qualifications, supplier and internal audits
Interim site management: start-up, vacancy or restructuring — several roles in one person
Documentation: SOPs, change control and CAPA processes that work in practice

Quality management Request a quote

Where to meet us

Come and talk to us at the following events

29 Apr 2026 — Grand opening of the BioCampus Cologne Shared Lab for Life Sciences
19 May 2026 — BioStoffTag 2026, Bundespresseamt Berlin
09–12 Jun 2026 — Annual congress of SOFAQ, Institut Pasteur de Lille
09–11 Jun 2026 — bio:cap Europe, Berlin
17–18 Sep 2026 — Annual Meeting of the German Quality Management Association (GQMA), Dorint Hotel Sanssouci, Potsdam
23–26 Feb 2027 — Anuga FoodTec, Cologne
2027 — Annual Joint Conference of SOFAQ · RQA · GQMA, Strasbourg

Who we work with · International clients

Your guide to German regulations For international companies opening a site in Germany — and for non-German-speaking founders starting a business here.

German permits, notifications and occupational safety rules are detailed — and mostly written in German. We explain what applies to you in English, prepare the documents and talk to the authorities, so your laboratory or business can start on schedule.

Talk to us in English

International Companies Opening a Site in Germany

Subsidiary · Branch office · New laboratory site

Your company is well established abroad — but German permits, notifications and occupational safety rules work differently. We guide your local team through the German requirements in English, so your new site can start on schedule.

How we help

Overview of the permits and notifications your site needs before operations start
Genetic engineering approvals (GenTG) and notifications for biological agents (BioStoffV)
Registration with the statutory accident insurance (Berufsgenossenschaft)
Appointment of an external safety specialist per §5 ASiG
Risk assessments, operating instructions and mandatory briefings in German and English
Interim site management while your local team is being built

Typical clients

Biotech and pharma companies setting up a German subsidiary
Contract research organisations opening a laboratory in Germany
Diagnostics companies expanding into the German market
Food and novel-food producers with fermentation or R&D sites

Request a quote Our services

Founders in Germany

For non-German-speaking founders and start-up teams

You live in Germany, you have a great idea — and the German paperwork is in German. We explain what applies to your business, prepare the documents with you and communicate with the authorities, so you can focus on building your company.

How we help

Which regulations apply to your planned activities — explained in plain English
Genetic engineering facility S1 / S2: project manager, biosafety officer and application documents
Occupational safety from day one: risk assessment, briefings, first aid and fire safety
German forms for the competent authorities — completed and coordinated with you
Templates for SOPs, operating instructions and training records
Support for your first inspection

Typical clients

Spin-offs from universities and research institutes
Start-ups in incubators, technology parks and shared labs
Founders of service laboratories and analytical start-ups
International researchers turning their research into a company

Request a quote Biosafety Officer services

Biotech & Life-Science Laboratories

GenTG · GenTSV · BioStoffV · GefStoffV

Research and development laboratories work with genetically modified organisms, biological agents and hazardous substances at the same time. We bring these requirements together in one consistent safety concept.

How we help

External project manager (§28 GenTSV) and biosafety officer (§29 GenTSV)
Notification, registration and approval of S1 and S2 facilities
Risk assessments for biological agents and hazardous substances
Operating instructions and annual briefings — supported by the SafetyCampus apps
Preparation for inspections by the competent authority

Typical clients

R&D laboratories in biotech and pharma
Cell and gene therapy developers
Fermentation and bioprocess facilities
Core facilities with shared labs and offices

Request a quote Genetic Engineering S2 app

Testing Facilities & Clinical Research

OECD GLP · GCLP · ICH GCP E6(R3)

Regulated studies in Germany require both a working quality system and compliance with German occupational safety rules. We support you with both — from the first GLP inspection to sponsor oversight.

How we help

GLP compliance programme and preparation for the national GLP inspection
GCLP for laboratories analysing clinical-trial samples
QA for study sites and sponsor-side QA under ICH GCP E6(R3)
Site qualifications, supplier and internal audits
Occupational safety for laboratories and archives

Typical clients

Toxicology, pharmacology and analytical test facilities
Contract research organisations (CRO)
Central laboratories for clinical trials
International sponsors without their own audit capacity in Germany

Request a quote Quality management

Chemical Products & Safety Data Sheets

REACH Annex II · CLP · GefStoffV

Selling chemical products in Germany? Your customers need a safety data sheet in German that meets REACH Annex II — prepared by a competent person. We create, review and update your SDS and make sure the German national requirements are covered.

How we help

Safety data sheets per REACH Annex II — in German, English and French
CLP classification and labelling of mixtures with a traceable calculation
Review of existing SDS from your headquarters or suppliers
Operating instructions per §14 GefStoffV based on your SDS
The SafetyCampus SDS Generator app for your own SDS team

Typical clients

Manufacturers outside Germany exporting to German customers
Importers and distributors of chemicals and mixtures
Manufacturers of laboratory reagents and kits
Start-ups with their own formulations

Request a quote SDS Generator app

Shared Labs, Incubators & Research Campuses

Operators · Tenants · Core facilities

Shared laboratory space attracts international teams — and every tenant brings its own activities, organisms and substances. We help operators and tenants define clear responsibilities and keep the whole building compliant.

How we help

Safety concepts for shared laboratories and common areas
Clear split of responsibilities between operator and tenants
Genetic engineering facilities for several tenants
Coordination of external contractors on site
Onboarding briefings for new tenant teams — in English and German

Typical clients

Operators of shared labs and lab coworking spaces
Incubators and technology parks
Research campuses with international start-ups
Core facilities serving several research groups

Request a quote Contractors Briefing app

Your external back office for your laboratory

SafetyCampusTraining apps and working tools that run in every browser

We share the same vision

Services and products for your organisation An independent outside view builds trust — your staff may come and go, but we stay by your side.

Your guide to German regulations For international companies opening a site in Germany — and for non-German-speaking founders starting a business here.

Has this sparked your interest? Get in touch today.

biosafety4u.berlin GmbH

News

Blog