Passionate People!

GxP Conseils

A consulting firm for the pharmaceutical, biopharmaceutical and agrifood sectors

Expertise

How can we help you?

Validation and Certification

"Ensuring the qualification of systems, equipment, and processes (IQ, OQ, PQ) with proper documentation in accordance with standards. Establishing and maintaining regulatory compliance."

Engineering

Design, engineering studies, procurement, and manufacturing control of equipment. Construction, commissioning, and optimization of existing facilities, equipment, or processes.

Maintenance

Support and improvement of preventive and corrective maintenance processes for equipment and systems. Execution of maintenance tasks by technical experts, with documented evidence.

Project Management

Management of key project components — budget, resources, scheduling, monitoring, and facilitation — within an interdisciplinary context and through interdepartmental coordination

Clean Utilities

Design of utility systems including purified water, water for injection (WFI), compressed air, steam, and nitrogen, along with technical support for HVAC systems.

Process

Support in the design and optimization of manufacturing processes to enhance operational performance and ensure compliance.

Start-Up

Commissioning of equipment and systems, ensuring proper utility connections and verifying operational performance in accordance with specifications.

Commissionning

Verification of the design and installation of components and systems through testing in accordance with operational requirements, supported by appropriate documentation. Drafting of Standard Operating Procedures (SOPs).

Compliance

Regulatory compliance assessment through audits, support during inspections (before, during, and after), gap and risk analysis, and implementation of CAPA plans.

Quality

Support in the design, implementation, or evolution of a quality management system based on risk management principles and phased development, in accordance with regulatory requirements.

Our Team!

Our team of consultants has strong expertise in the pharmaceutical, biopharmaceutical, agri-food, and cosmetics sectors.
We support you with dedication and efficiency. Contact us to learn more.