HERE

The construction of pharmaceutical and GMP-compliant production facilities requires close integration of technical planning, regulatory requirements, and architectural implementation. Our engineering team combines profound knowledge of construction and planning law with a deep understanding of GxP and process requirements – thus creating economically viable, legally sound, and regulatorily compliant solutions for every project phase.

Fields

Conversion of Existing Buildings

Modernizing existing facilities or adapting them to new production processes places high demands on planning and execution. We develop customized conversion concepts that optimally integrate existing structures while meeting all building law, safety, and regulatory requirements – without disrupting ongoing operations.

New Construction

For the new construction of pharmaceutical factories and production facilities, we combine architectural creativity with technical precision and legal certainty. Our interdisciplinary planning teams design efficient, sustainable, and GxP-compliant buildings that perfectly balance functionality, future viability, and economic efficiency.

Modernization

Increasing regulatory requirements and technological developments make regular modernizations essential. We analyze existing infrastructures, identify optimization potential, and implement innovative solutions that ensure energy efficiency, operational safety, and long-term compliance.

Engineering

Based on the analysis of process / GxP specifications, consulting / concept development regarding structural feasibility is provided.

Following the analysis of relevant process and GxP specifications, expert consultation and the development of a structural implementation concept are provided, considering regulatory and technical requirements.

Object and General Planning: Extended design and approval planning including the preparation of building applications, approval applications according to BImSchG, and execution planning

As part of our object and general planning, we offer all architectural services from extended design and approval planning to detailed execution planning.

Based on technical and GxP-specific requirements, we develop holistic concepts that combine function, design, and economic efficiency.

Our services include:

  • Preparation and coordination of building permit documents
  • Processing of approval applications according to BImSchG (Federal Immission Control Act)
  • Integration of technical planning disciplines into the overall planning
  • Development of execution documents for precise, legally compliant implementation

Additional services in approval planning:

  • Escape and rescue route plans according to current safety and workplace guidelines
  • Fire protection concepts tailored to operational and structural requirements
  • Static calculations and structural engineering for safe and economical constructions

Through close coordination of all trades, we ensure that every project, from concept phase to realization, meets the highest technical, design, and regulatory standards.

Turnkey realization as general contractor for excavation, shell construction, roof, facade, interior finishing, cleanroom fit-out

As a general contractor, we undertake the complete turnkey realization of your projects – from excavation to cleanroom fit-out and qualification. Through the close integration of all trades, we guarantee smooth processes, highest quality, and on-schedule and on-budget implementation. Thanks to our interdisciplinary planning and many years of experience in the construction of production and laboratory buildings, we create optimal conditions for future operations – functional, economical, and regulatorily compliant.

Ensuring all structural measures, regulatory requirements, and international standards

We ensure that all structural measures comply with applicable regulatory requirements and international standards. From the outset, we consider all relevant GxP, GMP, and building law regulations, as well as national and international guidelines.

Through our interdisciplinary planning and many years of project experience, we guarantee:

  • full compliance with legal and official requirements,
  • technical and structural implementation according to international standards,
  • and the seamless integration of these requirements into planning, construction, and documentation.

This results in projects that not only impress technically and economically, but also offer the highest regulatory security – today and in the future.

Support for Official Approvals

We provide comprehensive support to our clients for all official approvals and authorization procedures. From preparing the necessary documents and coordinating with the responsible authorities to participating in on-site inspections – we professionally and transparently accompany the entire process.
Through our experience with building, immission control, and hygiene law procedures as well as regulatory requirements in the GxP environment, we ensure that all inspection and approval processes are carried out efficiently, completely, and in compliance with regulations.

References

Extension K505 (Bayer Bitterfeld AG)

Expansion of production building K505 by adding a two-storey extension with a rooftop technical penthouse, providing 2,990 m² gross floor area for OSD manufacturing & packaging

  • Extended design and permitting planning
  • Turnkey implementation of the following trades
    • Extended structural shell
    • Interior fit-out
    • MEP
    • Cleanroom interior fit-out
    • EMS; BMS
    • Process media
  • Qualification through to the end of OQ
View Project

Production Modernization (Dr. Kade Pharmazeutische Fabrik GmbH)

Modernization of the entire production area for ointments, gels, and suppositories, GFA 1,700 m²

Preparation of extended design planning for the modernization of the entire production facility as well as the turnkey implementation of the following trades:

  • technical building services
  • cleanroom interior fit-out
View Project

Project MOVE / Realization of R Laboratories 3rd and 4th Floor (Kulzer GmbH)

Consolidation of all research and development laboratories (2,000 m²) from the Wehrheim site to Kulzer GmbH’s headquarters in Hanau, into an existing, gutted industrial building. Extended design and approval planning, as well as the turnkey realization of the trades.

  • Laboratory Furniture
  • Climate-Controlled Rooms
  • Ultrapure Media
  • Ventilation
  • Electrical
  • Utilities
  • MSR
  • Steel Construction and Interior Fit-out
View Project

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Konstantinos Baltzis

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Rim Abdmouleh

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Thomas Mannecke

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Stefan Stemmle

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