Life Sciences
Specialized engineering for pharmaceutical, biotechnology, and healthcare manufacturing facilities.
Industry Overview
The life sciences sector demands the highest standards of quality, sterility, and regulatory compliance. We provide comprehensive consulting services for pharmaceutical manufacturing, biotech facilities, medical device production, and research laboratories. Our expertise ensures projects meet stringent GMP, FDA, and international regulatory requirements while optimizing operational efficiency and product quality.
Sectors We Serve
Pharmaceutical Manufacturing
API production, formulation facilities, sterile manufacturing, and packaging lines for drugs and vaccines.
Biotechnology
Bioreactors, cell culture facilities, protein purification, gene therapy production, and biologics manufacturing.
Medical Devices
Clean room manufacturing, device assembly, sterilization facilities, and quality control laboratories.
Research & Development
Laboratory design, pilot plants, analytical facilities, and research infrastructure for drug discovery and development.
Our Services for Life Sciences
GMP facility design and engineering
Cleanroom and controlled environment design
Process equipment selection and validation
Regulatory compliance consulting (FDA, EMA, GMP)
Commissioning and qualification (IQ/OQ/PQ)
Technology transfer and scale-up support
Technical Expertise
Aseptic processing and sterile manufacturing
HVAC and contamination control systems
Water for injection (WFI) and purified water systems
Process validation and equipment qualification
Cleanroom classification and monitoring
Biosafety and containment design
Cold chain and controlled storage systems
Automation and process control (21 CFR Part 11)
Industry Challenges We Address
Regulatory Compliance
Life sciences facilities must meet stringent GMP, FDA, and international regulations requiring extensive documentation, validation, and quality systems.
Contamination Control
Maintaining sterility and preventing contamination requires sophisticated cleanroom design, air handling systems, and operational procedures.
Rapid Innovation
Fast-evolving technologies like cell therapy, gene editing, and personalized medicine require flexible facilities that can adapt to new processes.
Quality and Validation
Extensive validation, qualification, and documentation requirements add significant time and cost to project delivery and changes.
Our Life Sciences Track Record
Featured Projects
Biopharmaceutical Manufacturing Facility
Success StoryDesigned and managed construction of greenfield biologics manufacturing facility with multiple production suites and quality control laboratories.
Results Achieved:
$300M facility completed on schedule, FDA pre-approval inspection passed, achieved commercial production within 18 months.
Vaccine Production Scale-Up
Success StoryLed rapid expansion of vaccine manufacturing capacity in response to global health emergency, including tech transfer and validation.
Results Achieved:
Capacity increased 10x in 9 months, maintained GMP compliance throughout, enabled production of 500M doses annually.
Cell Therapy Manufacturing Facility
Success StoryDeveloped specialized facility for autologous cell therapy production with patient-specific manufacturing suites and cryopreservation.
Results Achieved:
ISO Class 5 cleanrooms operational, achieved 99.5% batch success rate, supported regulatory approval for commercial therapy.
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