Pharmaceuticals & Biotech
Automation, digitalization, and optimization solutions for life science industries
Production in the pharmaceutical and biotech industries is characterized by the highest standards of product quality, documentation and product safety. In view of global markets and increasing digitalization, life science companies are now required to ensure qualitative product safety, data integrity and traceability.
Due to the increased requirements of the FDA, data integrity & traceability, a high level of automation and digitalization are almost mandatory to ensure operational performance.
Our team supports the life science industry worldwide with automation, digitalization, and optimization solutions throughout the production chain.
Orise provides solutions and services across the lifecycle of your automation assets, deploying best practices with project management, control strategies and design across multiple automation controller platforms. As a global system integrator in the pharma and biotech business, we have the ability to scale and standardize our solutions on local, regional, and international levels.
#pharma
Pharmaceuticals
– Line monitoring solutions
– DCS / SCADA systems
– Recipe control following the ISA S88 and S95 standards
Orise also specializes in digital transformation to enable paperless manufacturing. Solutions include:
- MES (Manufacturing Execution Systems)
- EBR (Electronic Batch Records)
- LIMS (Laboratory Information Management Systems)
- Data historian and manufacturing intelligence systems
- IT/OT security and reliability methodologies
- Business process modeling and requirements engineering
- Qualification and validation in alignment with GAMP5 standards
#biotech
Biotechnology
Orise delivers comprehensive upstream and downstream automation, including media preparation and utility integration. Expertise includes:
- Collaboration with skid suppliers for seamless implementation
- Experience in single-use equipment integration
- Execution of large DCS (Distributed Control Systems) and MES projects with batch processing compliant with ISA88 standards
Orise also advances biotechnology operations with digital transformation initiatives, promoting paperless manufacturing through MES, EBR, LIMS, and other intelligence systems.
#formfillfin
Formulation, Fill, and Finishing
- Automated filling lines with integrated quality control measures
- Seamless batch management and traceability for formulation processes
- Scalable solutions to adapt to varying production volumes and product specifications
- Validation and qualification to meet stringent regulatory standards
With Orise’s expertise in FFF operations, companies can improve throughput, minimize operational risks, and maintain the highest quality across finished products.
#cmo
Contract Manufacturing Organizations (CMOs)
Orise collaborates with contract manufacturing organizations to streamline production and ensure compliance with industry regulations. Orise supports CMOs in:
- Scaling operations to meet increased production demands
- Implementing robust MES and EBR systems for traceability and reporting
- Automating quality control processes to reduce manual interventions
- Integrating supply chain and production for end-to-end visibility
- Ensuring regulatory compliance through validation services tailored to GAMP5 and FDA regulations
Partnering with Orise enables CMOs to maximize efficiency and gain a competitive edge in contract manufacturing, delivering high-quality products on time and within budget.
#meddevice
Medical Devices
- Design, build, and maintain solutions for automation and digitalization
- EI&C project execution
- Engineering (EPCM)
- Turnkey project delivery (EPC)