Biosafety · Occupational Safety & Health · Quality Management
Administrative services 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 concept phase through operations to retirement.
Biosafe 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 — preventative approach that motivates your team.
Quality Management GLP, GCLP, GCP, ISO alignment, sponsor oversight, interim COO or site manager, external QA back-up.
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 license fees. Built from day-to-day advisory experience in German labs and genetic-engineering facilities.
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 the retirement phase.
This approach also helps ease the coordination with the relevant regulatory authorities.
We prioritize a collaborative consulting style, bringing all key stakeholders together to the same table for more effective decision-making.
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
Fulfil your legal obligations under Section 12 of the German Occupational Safety and Health Act (ArbSchG) and Section 6 of the Workplace Ordinance (ArbStättV). Content based on ASR A6 and DGUV Information 215-410.
What you get
10 interactive learning modules
20 interactive comprehension questions
PDF confirmation of participation with digital signature
Long-term electronic archive designed around the German Genetic Engineering Record-Keeping Ordinance (GenTAufzV) — ideal for large organizations maintaining multiple sites across Germany.
What you get
Retention periods 15 or 30 years per GenTAufzV out of the box - RFC-3161 time stamp
Tamper-evident storage with change history and audit trail, inspection-ready export — single-click bundles
Role-based access for Biosafety officers, operators, project managers, and lab personnel
2FA authentification via the Authenticator app
FDA part 11 and GAMP 5 compliant - ALCOA+ implemented - fully validatable with DQ/IQ/OQ/PQ documentation
eLabFTW compatible ELN export - interface to your e-labbook and open source LIMS eLabFTW
Services and products for your organisationThe neutral view from outside creates confidence — your employees come and go, we stay by your side.
Services for Biosafe Genetic Engineering
Biosafety Officer · Beauftragter für biologische Sicherheit (BBS)
Simply add us to your genetic engineering facility as an external Project Manager in accordance with §28 of the German Genetic Engineering Safety Ordinance (GenTSV) or external Biosafety Officer in accordance with §29 GenTSV.
We assist you in navigating the approval processes with competent authorities for GMO facilities (image kindly shared with permission of one of our clients).
Officially confirmed in ten federal states of Germany
New in 2025: Biosafety officer for schools running GMO experiments — see our FAQs (German)
Consulting Services & Sifa 3.0
Administrative Consulting
We answer your questions and create all necessary documents for you in German and English:
Standard operating procedures, policies, manuals and handbooks
AI-assisted visualisation of complex process landscapes, org charts, flow diagrams (Canva, Lucidchart)
Quality documents such as change-control and CAPA records
Operating instructions for biological agents, hazardous materials, equipment and procedures
A large panel of separate templates ready to use inside your organisation
We organise sample imports from outside the EU, obtain permits for handling animal by-products per EU Regulation (EC) 1069/2009, and help you complete German forms for the competent authorities following good communication practice.
Occupational Safety & Health · Sicherheitsfachkraft (Sifa 3.0)
New in summer 2025 and in line with DGUV Regulation 2 (2024). The German Act on Occupational Physicians and Safety Engineers (ASiG) requires top management to appoint an occupational safety specialist.
Appoint us as your external safety specialist per §5 ASiG. We motivate your teams through a preventative OSH approach, coordinate with the Berufsgenossenschaft and your responsible authority.
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, hazardous substances — with multiple-choice tests and confirmation of participation.
Apps are designed as practical tools to streamline your workflow: from creating legally compliant safety data sheets (SDS) to guaranteeing long-term retention in electronic archives.
Trainings and Instructions · Schulungen und Unterweisungen
Setting up your own facility and need foundational knowledge that fits your plans? We help you align everything with current expectations — get inspection-ready with a remote or on-site roundtable seminar.
Your requirements always come first: we tailor the content to your needs.
Administrative or operational seminars, plus internal training support
Understand which approvals you need to run a life-science facility in Germany
Introduce or refresh your quality-management system
OECD Principles on Good Laboratory Practice (GLP)
OECD GLP special topics: QA and GLP, multi-site studies, GLP-compliant archives
Computerised systems life-cycle management (GLP / GCP / GAMP 5®)
Good Clinical Laboratory Practice (GCLP) for laboratories processing clinical trial samples
Sponsor responsibilities under ICH GCP (E6)R3, annexes 1 and 2
Clinical investigator oversight in line with GCP
Quality Management & Quality Assurance
Qualitätsmanagement · interim site manager, GLP / GCLP / GCP
Add us to your organisation as an interim site manager or operating officer (COO), a short-term QA backup, or permanent external QA support. As a study sponsor without audit capacity, use us for site qualifications.
Good Laboratory Practice (GLP): a client asks you to characterise test articles in a regulatory non-clinical setting? See our GLP leaflet on aligning your QA programme to GLP.
Good Clinical Laboratory Practice (GCLP): planning to analyse clinical-trial samples? See our GCLP leaflet to add value to your ISO-aligned QA programme.
Good Clinical Practice (GCP): participating in a clinical trial as a study site, or setting up your own sponsor-side QA programme compliant with current ICH GCP? Contact us today.
Where to meet us
Please feel free to liaise during the following events
