We support tech transfer activities between R&D, manufacturing or external partners. Our consultants ensure a smooth transition of knowledge, documentation and critical process parameters, helping align stakeholders while safeguarding compliance and product continuity.

Our mechanical engineers support the design, installation and optimisation of systems such as piping networks, HVAC infrastructure and process equipment within GMP or industrial environments. We help ensure that mechanical systems are fit-for-purpose, efficient and compliant.

We manage electrical and instrumentation systems from concept to commissioning. This includes panel design, cabling, sensor configuration, loop checks and safety system integration. Ensuring your installations meet operational, safety and compliance requirements.

Our automation engineers design and implement control systems tailored to your operations. We program and troubleshoot PLCs, SCADA systems and distributed control systems such as DeltaV or MES platforms, aligning automation logic with GMP-compliant process flows.

We qualify laboratory equipment following IQ/OQ/PQ protocols to ensure precision and data reliability. This includes instruments like HPLC, GC, MS, ELISA, PCR, balances, pH meters, incubators and other analytical or support tools used in QC and R&D settings.

Our consultants qualify key production equipment such as bioreactors, centrifuges, filling lines, filtration systems and other critical assets. We ensure that each unit performs consistently under predefined operating conditions, aligned with regulatory expectations.

We support the qualification of GMP-critical utilities and facilities, including cleanrooms, HVAC systems, water systems (WFI, PW), compressed air and gas distribution networks. This ensures your infrastructure is validated and inspection-ready.

We support the full process validation lifecycle, from design to PPQ and Continued Process Verification (CPV). Our consultants help define a science- and risk-based process design, execute PPQ to confirm consistent manufacturing and implement CPV to ensure ongoing control and regulatory compliance.

Our cleaning validation talents define and validate cleaning procedures to prevent cross-contamination. We cover sampling techniques, worst-case product assessments, residue limits and re-cleaning criteria. All aligned with GMP standards.

We support validation of sterilisation processes such as autoclaving, dry heat and gas-based sterilisation. Our consultants handle cycle development, biological indicator studies, load mapping and documentation to meet regulatory requirements.

We assist in validating analytical methods according to ICH Q2(R2) guidelines. This includes validation for parameters such as accuracy, precision, linearity, specificity, limit of detection and robustness. Supporting both in-house and outsourced labs.

We ensure digital system compliance across lab, production and enterprise platforms.

• For lab systems like Empower and LIMS, we validate audit trails, access controls and data integrity.
• For production systems like PLC, SCADA, DeltaV and MES, we apply GAMP 5 and 21 CFR Part 11 principles to ensure safe automation.
• For company-wide systems like ERP and SAP, we validate business-critical processes that impact product quality or regulatory reporting.