Dedicated to Regulated Manufacturing
We work exclusively within the Life Sciences sector, giving us unparalleled depth of understanding in pharmaceutical, biotech, and medical device manufacturing environments.
Pharmaceutical Manufacturing
Supporting the full spectrum of pharma manufacturing — from API production through formulation, filling, and packaging. We help implement and validate the digital infrastructure that ensures product quality, batch consistency, and regulatory compliance.
- Batch record automation & EBR systems
- Serialisation & track-and-trace
- Environmental monitoring systems
- Process analytics & PAT
Biotechnology & Biologics
Biotech manufacturing presents unique challenges — complex processes, sensitive materials, and rigorous documentation requirements. We bring specialised expertise in the digital and automation systems that support biomanufacturing at every scale.
- Bioreactor monitoring & control
- Upstream & downstream process integration
- Single-use technology systems
- Scale-up & tech transfer support
Medical Devices
Medical device manufacturing demands precision, traceability, and quality at every step. We help device manufacturers implement the IT and automation systems needed to meet ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
- Device history record (DHR) automation
- Production line automation
- UDI & labelling systems
- Quality management integration
Cell & Gene Therapy
The emerging field of advanced therapy medicinal products (ATMPs) requires innovative approaches to manufacturing IT. We support cell and gene therapy manufacturers in building the digital foundation for personalised medicine production.
- Chain of identity & custody tracking
- Autologous & allogeneic workflow management
- Cleanroom monitoring & control
- Vein-to-vein traceability
Standards & Frameworks We Work With
Our consultants maintain expertise across the key regulatory standards and industry frameworks that govern Life Sciences manufacturing.
FDA Regulations
21 CFR Part 11 (electronic records), 21 CFR Part 210/211 (cGMP), 21 CFR Part 820 (medical devices).
EU GMP
Annex 11 (computerised systems), Annex 15 (qualification & validation), EU GMP Parts I & II.
GAMP 5
Risk-based approach to GxP compliant computerised systems, including CSA (Computer Software Assurance).
ISA Standards
ISA-95 (enterprise-control integration), ISA-88 (batch control), ISA/IEC 62443 (cybersecurity).
Data Integrity
ALCOA+ principles, MHRA data integrity guidance, WHO guidelines on data integrity.
Quality Standards
ICH Q guidelines, ISO 13485, ISO 9001, PIC/S guidelines.