Services · Berlin
Partnership for the entire lifecycle of your laboratory
From your first sketch to the day you decommission a facility, we stand alongside your team as an outsourced back-office for biosafety, occupational health and quality — complemented by our partner network. Choose where you need us most; the details are one click away.
§28 / §29 GenTSV · officially confirmed in 11 federal states
Biosafety in Genetic Engineering
Your external Project Manager and Biosafety Officer — walking with you from the concept phase through operation to decommissioning.
What you get
- Appointment as external BBS under §29 GenTSV
- Registration, notification and approval dossiers (S1–S2 per §8 / §9 / §10 GenTG)
- Risk assessments, SOPs and lab instructions per §12 GenTSV
- Coordination with the competent authorities in all federal states
- Annual reviews, inspection-readiness and audit accompaniment
- Handover documentation for facility decommissioning
Sifa 3.0 · §5 ASiG · DGUV Vorschrift 2
Occupational Safety & Health
A safety specialist (Sicherheitsfachkraft) who works with your team, not against it — preventive, pragmatic and motivating.
What you get
- External Sifa services per §5 ASiG and DGUV Vorschrift 2
- Risk assessments for laboratories, offices and home offices
- Instructions per §12 ArbSchG and §14 BioStoffV
- ASA meetings prepared, chaired and minuted
- Ergonomics briefings and workplace assessments
- Incident review and preventive action plans
OECD GLP · ICH GCP E6(R3) · GCLP · ISO 9001 · ISO 45001
Quality Management
Sponsor oversight, interim leadership and external QA back-up — so your quality system keeps its rhythm.
What you get
- GLP, GCLP and GCP gap analyses and remediation plans
- ISO 9001 quality management systems — build, mature or audit
- ISO 45001 occupational health & safety management — integrated with your Sifa work
- Sponsor oversight and CRO / lab qualification
- Interim COO, site manager or QA lead
- GAMP 5 lifecycle support for computerised systems
- Audit preparation and CAPA management
Roundtable seminars · Word & digital templates · AI-assisted
Training & Templates
Ready-made instructions in the format your inspectors expect — plus small-group seminars and AI-assisted tools for the lab of tomorrow.
What you get
- Roundtable seminars, remote or on-site (EN / DE / FR)
- Instructions per §12 ArbSchG, §14 BioStoffV and §17 GenTSV
- LAG-compliant application forms in Microsoft Word — text blocks, images, flow charts
- SafetyCampus browser apps: AI-assisted SDS generation, screen workstation, genetic engineering and contractor briefings
- AI copilots for regulatory drafting — risk assessments, SOPs, inspection prep
- Onboarding kits for new laboratory staff
Partner network · Berlin & beyond
Lab space & ecosystem, powered by Cellcolab
Need the lab itself — not just the paperwork? Through our partner Cellcolab you plug into a fully-equipped life-science ecosystem while we take care of compliance.
What you get
- Fully equipped, agile lab space — short-term or long-term
- Life-science incubator management and shared infrastructure
- Contract research capacity and equipment (buy / sell / rent)
- Landing pad for international teams entering the German market
- Talent search and hiring support
- Financing and consulting through the Cellcolab ecosystem
Has this sparked your interest? Get in touch today.
How can we help? We look forward to hearing from you.
biosafety4u.berlin GmbH
Schulzestraße 20
13187 Berlin
E-Mail: service@biosafety4u.berlin
Mobile: +49 (0)157 75726939
@biosafety4u.berlin:matrix.org
