We help you realize your ideas

Our consulting engineering company offers a wide range of services in pharmaceutical & biotechnological industry. With our flexible business strategy, we propose a quick resources mobilization and a transparent execution.

Our services‍

Our significant projects

Major mandates realized by our firm in recent years

Vaccines industry CQV

Management and coordination of diverse equipment qualification, spanning from laboratory analyses to upstream and downstream processes. We manage all communication with suppliers and services providers, while also supporting the site Project Manager in scheduling activities and coordinating between different actors of the new site. Our responsibilities encompassed generating and revising protocols, executing qualification protocols, reviewing results, documenting and mitigating deviations, and generating reports. Additionally, we contributed to the generation and revision of Standard Operating Procedures (SOP).

Laboratory software configuration, commissioning and validation (CSV)

Defining needs, configuration, commissioning, and validation of a computerized laboratory sample management system. Our services included vendor qualification, GxP assessments on the software, software configuration according to client requirements, and staff training. We also wrote a CSV Validation Project Plan (VPP), DS, and other specifications, as well as SOPs for the new software. Additionally, we reviewed supplier qualification documents, wrote and executed complementary CSV tests, as well as qualification reports. Our role encompassed project management, scheduling, conducting weekly progress meetings, and diligent follow-ups to ensure success.

Quality System implementation

We wrote, audited and reviewed the entire quality system for the client. It included SOPs generation, supplier audits and qualifications, equipment and software qualification, CAPA & change request, maintenance and calibration, and business continuity. This project was part of the client preparation for ISO 9001 certification.

Sterile products manufacturing industry commissioning

Commissioning and validation project management for a new biotechnology manufacturing site (Clinical Phase I). Our responsibilities included planning and following up on the schedule, monitoring the budget, and any revaluation of the mandate. We served as the main line of communication between the engineering firm, construction, and validation teams. Additionally, we coordinated trainings, access, and technicalities for all validation consultants on site and were responsible for the overall completion of the validation project.

Smoke test protocol

End-to-end management of a smoke test project in a pharmaceutical sterile environment. From conceptualization to Health Canada approval, we oversaw every aspect. Managing timelines, schedules, and personnel, we ensured seamless operations. Our services encompassed protocol generation, approvals, follow-up, and meticulous documentation support. We also coordinated with an external film company for pre-execution organization and conducted comprehensive video reviews post-
execution for the regulatory submission.

Continuous and specialized training

Customized training program including hands-on exercises.
We develop tailored content based on your specific needs, including exercise materials for a dedicated practical component. The presentation includes theory and applicable standards & regulatory references, real-life examples, as well as interactive quizzes. The application phase features group work, concrete tasks, and guided reflection to arrive at the most effective approach.

Continuous improvement of a technology transfer process

Identification of the operational workflow, identification of weaknesses, and recommendation of tools to improve process control. All personnel involved in managing material and information flows were interviewed to obtain a clear representation of the situation (process mapping) and to assess stakeholders as well as their roles & responsibilities. Safeguards were added to written procedures to address gaps, and tools were developed to facilitate collaboration.

BAS modification

The engineering department of the pharmaceutical company was overwhelmed by alarms and notifications generated by the Building Automation System (BAS). Monbel assessed the manufacturer’s needs and proposed an action plan to reconfigure alarm parameters in order to preserve the BAS qualification status. All BAS alarms were evaluated as part of an in-depth risk analysis, tested, and modified according to the identified needs. Monbel managed the assessment, modification, and final testing of the BAS configuration adjustments.

Maintenance and reassessment of calibration ranges

Out-of-specification (OOS) results were obtained on twenty-three (23) balances and moisture analyzers over two-year period. Following an in-depth review of the documentation and the qualification of the parameters for the balances & moisture analyzers, it was determined that the calibration ranges and maintenance schedules did not reflect the intended use & application, in accordance with ISO 17025:2017 and USP chapter <1251>. A risk analysis was conducted to adjust the ranges and ensure that all equipment operates within the desired tolerances, while minimizing potential risks to product quality and safety.

Design and relocation of a semi-solid production line

The manufacturer of semi-solid pharmaceutical products operated two production lines for the packaging of semi-solid creams: one for aluminum containers and the other for plastic containers. All steps following the initial filling were identical on both lines, operating at a rate of 35 tubes per minute. Some packaging equipment were shared between the two lines, requiring multiple adjustments and the use of mobile equipment. To improve line efficiency and reduce setup times, Monbel designed and modified the existing lines to merge them into a single production line. The new line accommodates both plastic and metal tubes, enables accurate weighing, serialization and final packaging, while minimizing product damage. No new equipment were required, as Monbel reused and modified existing equipment. Monbel also assessed qualification requirements, electrical needs and coordinated the project across departments to minimize production downtime.