Administrative Services for your laboratory

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, as depicted in the image (shared with the kind permission of one of our clients).

Already officially confirmed in ten (10) federal states of Germany:

Baden-Württemberg
Bayern
Berlin
Brandenburg
Hamburg
Hessen
Mecklenburg-Vorpommern
Niedersachsen
Nordrhein-Westfalen
Thüringen

Examples of facilities for genetic engineering are:

Novel Food ingredient production
Non-clinical research facility
Distributor
Research and development laboratory
GxP archive
Core facilities with shared labs and offices
NEW in 2025: Biosafety officer for schools experimenting with genetically modified organisms, please click here to check our FAQs.

Take a look at our information on the Biosafety Officer services, and feel free to forward it to other interested parties.

Administrative Consulting

We answer your questions and create all necessary documents for you in German and English.

• Standard operating procedures, policies, and manuals/handbooks;
• AI-supported visualization of complex process landscapes, organisational charts, flow diagrams, etc. applying tools like Canva and Lucidchart;
• Quality-related documents, e.g., like change control or corrective and preventive action (CAPA) documentation;
• Operating instructions for biological agents, hazardous materials, equipment, procedures, etc;
• Huge panel of separate documents and templates for use within your organization or laboratory;

We organize the sample import from outside the European Union.

We help you getting the permit for handling animal by-products within your facility according to the EU Regulation (EC) No. 1069/2009.

We help you understanding and completing German forms for document submission to your competent authority following good communication practice.

Occupational Safety & Health (OSH) | Sicherheitsfachkraft (Sifa 3.0)

NEW in summer 2025 and in accordance with DGUV Regulation 2 "Company physicians and occupational safety specialists" (2024).

The Act on Occupational Physicians, Safety Engineers and Other Occupational Safety Specialists (in German: Arbeitssicherheitsgesetz, ASiG) requires the top management of an organization to appoint company medical officers as well as occupational safety specialists for occupational safety and health (OSH).

As the top manager of your organization, appoint an occupational safety specialist for your laboratory or production facility in Germany according to §5 ASiG (in German: Sicherheitsfachkraft Sifa 3.0 = Fachkraft für Arbeitssicherheit).

We are here to help you add value to your business and motivate your employees through a preventative approach to occupational safety and health.

We will be happy to contact the supervisor of your employers' liability insurance association (in German: Berufsgenossenschaft), and we will coordinate with your responsible occupational safety authority.

Trainings and Instructions | Schulungen und Unterweisungen

Remote training sessions and in-house seminars - You’re looking to set up your own facility and need foundational knowledge that fits with your plans?

We assist you in aligning everything with current expectations - Get inspection-ready and inquire about a remote or on-site roundtable seminar.

Your requirements always come first: We compile the content according to your needs.

Schedule administrative or operational seminars, and ask for internal training support:

• ... to get an idea which approvals you need to run your life science facility, and how to navigate the complex German regulatory landscape;
• ... to meet legal requirements, e.g. the instruction in accordance with §12 of the Occupational Health and Safety Act (ArbSchG);
• or the instruction according to §14 Biological Substances Ordinance (BioStoffV);
• or the instruction as required in §17 Genetic Engineering Safety Ordinance (GenTSV);
• YOUR FIELD OF INTEREST;

Introduce a quality management system, or organize a refresher course:

• OECD Principles on Good Laboratory Practice (GLP);
• OECD GLP special topics, e.g., quality assurance and GLP, the management of GLP multi-site studies, establishment and control of GLP-compliant archives;
• Computerized systems life cycle management in line with GLP, GCP, and/or GAMP 5 ®;
• Good Clinical Laboratory Practice (GCLP) for laboratories processing clinical trial samples;
• Clinical trial sponsor responsibilities oversight and risk assessment as outlined in ICH GCP (E6)R3 with annex 1 and 2;
• Clinical investigator responsibilities oversight in line with GCP;

Quality Management and Assurance | Qualitätsmanagement

You can add us to your organisation if you are seeking an interim site manager or operating officer (COO).

Your quality assurance (QA) needs a short-term backup, or you require a permanent QA support from external?

You are a study sponsor and do not have auditing capacities for site qualifications?

Good Laboratory Practice (GLP): You have a client asking you to characterize test articles in a regulatory non-clinical setting? Please have a look at our Good Laboratory Practice (GLP) leaflet on how we can help you aligning your current quality assurance program to GLP regulations.

Good Clinical Laboratory Practice (GCLP): Your laboratory is planning to perform the analysis or evaluation of clinical trial samples? Please have a look at our Good Clinical Laboratory Practice (GCLP) leaflet on how we can proactively add a value to your current ISO-aligned QA program.

Good Clinical Practice (GCP): If you are planning to participate in a clinical trial as a study site, or you are a study sponsor who needs to set-up its own QA programm compliant to current ICH GCP expectations, you should contact us today.

Please feel free to liaise during the following events:

19-20 März 2024 ANUGA Food Tec (Köln, Germany)

16-17 April 2024 German Biotechnology Days 2024 | Deutsche Biotechnologietage 2024 (Berlin, Germany)

19-20 September 2024 GQMA 28. Annual Conference of the German Quality Management Association (Neuss, Germany)

14-15 October 2024 Potsdam Science Park Conference (Potsdam, Germany)

10-12 December 2024 FDA Clinical Investigator Training Course (CITC) 2024 (participating online)

13-14 January 2025 EFGCP Principles of Clinical QA Auditing (participating online)

19-20 February 2025 European Medicines Agency (EMA) ACT EU workshop on ICH E6 R3 principles and Annex 1 (participating online)

25 February 2025 Cluster meets: Essential MDR-Requirements – Overview and Experience Exchange (participating online)

09-10 April 2025 German Biotechnology Days (Heidelberg, Germany)

01 April 2025 BioStoffTag 2025 - Der ABAS im Dialog | Committee on Biological Agents (ABAS) (Berlin, Germany)

14-15 May 2025 The Conelis Competence Network Life Sciences goes BIONNALE 2025 (Berlin, Germany)

17-20 June 2025 Congrés 2025 de la SOFAQ Société Française d’Assurance Qualité (Strasbourg, France)

13-14 October 2025 Potsdam Science Park Conference (Potsdam, Germany)