(Bio)Pharmaceuticals

Pharmaceuticals & Biotechnologies.

In this industry, pharmaceutical and biotechnology firms along with research institutes work closely with professional orders and regulatory bodies to ensure the effectiveness and safety of products on the market.

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Services

We provide support in the following aspects:

Validation

Qualification (Equipment & Systems)

In order to comply with regulations and guarantee drugs’ reliability, equipment and systems qualification is essential (IQ, OQ, PQ), as they will directly or indirectly be in contact with the substances. Our engineers or experts ensure this step for our clients involved in manufacturing, packaging, storage or environmental control.

  • Drafting of the Master Validation Plan.
  • Drafting of technical documents.
  • Drafting of annual qualification reviews.
  • Drafting of SOPs and work instructions.
  • Training of technicians on procedures.
  • Drafting and execution of protocols (IQ, OQ, PQ).
  • Qualification reports.
  • Commissionning.
  • Equipment Qualification: production and packaging.
  • Systems Qualification: HVAC, AHU, purified water…
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Setup of remediation plans.
  • Multi-disciplinary collaboration.
Process Validation

This step, which aims to demonstrate that a manufacturing or packaging process will repeatedly deliver the same product quality, is critical for drug safety. Our consultants have a good grasp of the different processes used whether for liquid, semi-liquid, solid or sterile drugs.

  • Drafting of the Master Validation Plan.
  • Drafting of validation protocols.
  • Update of the validation matrix.
  • Setup of remediation plans.
  • Drafting of SOPs and work instructions.
  • Training of technicians on procedures.
  • Drafting of deviations, CAPA, change control.
  • Protocols execution and reports drafting.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Computer Systems Validation (CSV)

The drug industry uses today all kinds of softwares, apps and computer systems in its equipment and operational processes. Our consultants make sure that these IT tools comply with standards and guarantee the efficiency of operations, as expected.

  • Setting up of a validation strategy.
  • Drafting and execution of protocols (IQ, OQ, PQ).
  • Drafting of deviations, CAPA, change control.
  • Drafting of SOPs and work instructions.
  • Training of technicians on procedures.
  • Qualification reports.
  • Regulatory watch: GAMP 5, 21 CFR Part 11.
  • Setup of remediation plans.
  • Multi-disciplinary collaboration.
Cleaning Validation

Equipment, manufacturing areas and production staff must be subject to strict cleaning rules in order to avoid any risk of drug contamination. Our engineers help you set up and maintain the sanitation of your equipment and premises according to regulatory requirements.

  • Drafting of the Master Validation Plan.
  • Update of the cleaning matrix.
  • Manual and automated cleaning (CIP).
  • Drafting of SOPs and work instructions.
  • Drafting of deviations, CAPA, change control.
  • Sampling techniques: swabbing, rinsing…
  • Drafting of cleaning protocols.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Protocols execution and reports drafting.
  • Training of technicians on procedures.
  • Setup of remediation plans.
  • Multi-disciplinary collaboration.

Engineering

Technology Transfer

This process oversees the transition from development to industrial batches. It identifies which parameters are critical to reproduce the same quality attributes when scaling. Our consultants carry out this phase in full awareness of production scaling issues.

  • Management of process development projects.
  • Risk analysis: FMECA, QbD approach…
  • Identification of critical transfer parameters.
  • Scaling and optimization.
  • Drafting and execution of engineering batches.
  • Training of technicians on procedures.
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Process Engineering

Coming from the best schools in process engineering, our consultants ensure the design, acquisition and installation of equipment, premises and systems, in order to transform raw materials into therapeutic products with high added value, whatever the galenic form ( liquid, semi-solid, solid) of the drugs.

  • Management of process engineering projects.
  • Drafting of technical documents: FAT, SAT, URS.
  • Risk analysis: FMECA, QbD approach…
  • Design of P&ID, PFD.
  • Update of maintenance programs.
  • Setup of remediation plans.
  • Drafting of SOPs and staff training.
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Maintenance Engineering

With the increasing production rates, equipment and infrastructure maintenance is essential to meet demand. Knowing that any malfunction is a potential source of financial and regulatory impacts, our consultants support our partners' maintenance projects and design appropriate solutions.

  • Management of maintenance engineering projects.
  • Risk analysis: FMECA, QbD approach…
  • Design of preventive maintenance plans.
  • Execution and monitoring of works.
  • Setup of operational excellence processes.
  • Drafting of functional test protocols.
  • Training of technicians on maintenance.
  • Setup of remediation plans.
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Building Engineering

With regulatory requirements, energy efficiency and environmental in view, our consultants manage and oversee construction sites, maintenance activities or pharmaceutical buildings renovation, including the installation of ventilation, heating, electricity or plumbing systems.

  • Management of building engineering projects.
  • Need analysis, technical quotations…
  • Mechanical and electrical systems: HVAC, plumbing…
  • Design of technical blueprints and drawings.
  • Compliance with OHS standards.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Staff training.
  • Multi-disciplinary collaboration.
Project Engineering

Our consultants implement and manage all types of engineering projects that may occur in a pharmaceutical plant, within cost, deadlines and quality requirements. They ensure collaboration between the departments and teams concerned.

  • Management of engineering projects.
  • Design, budget, planning, monitoring and closure.
  • Validation, monitoring of deliverables and deadlines.
  • Validation of technical blueprints and drawings.
  • Compliance with OHS and GMF standards.
  • Staff training.
  • Multi-disciplinary collaboration.
Operational Effectiveness

Reducing energy and raw material costs and optimizing manufacturing processes are prime targets that our consultants work to achieve, thanks to a cartographic analysis of the context, and to a logic of operational efficiency and continuous improvement.

  • Management of operational excellence projects.
  • Setup of the DMAIC methodology.
  • Definition of Key Performance Indicators (KPI).
  • Validation and monitoring of deliverables and timelines.
  • Compliance with OHS and GMF standards.
  • Compliance with Health Canada and FDA standards.
  • Setup of remediation plans.
  • Staff training.
  • Multi-disciplinary collaboration.
Electrical Engineering

Given how high is the electrical consumption of the equipment and installations involved, our engineers and specialists manage every electrical design or maintenance project in an energy-efficient approach and in compliance with safety and pharmaceutical GMP standards.

  • Management of electrical engineering projects.
  • Design of electrical blueprints and diagrams.
  • Drafting of specifications and electrical quotations.
  • Validation and monitoring of deliverables and timelines.
  • Compliance with OHS and GMF standards.
  • Staff training.
  • Multi-disciplinary collaboration.
Automation Engineering

Necessary to the drug industry, automation consists in reducing human intervention in order to guarantee safety and increase productivity. With that in mind, our qualified consultants help our customers in their process automation projects.

  • Management of automation projects.
  • Design of automation plans.
  • Drafting of specifications and technical quotations.
  • Risk analysis: FMECA, QbD approach…
  • Drafting of technical specifications.
  • Functional analysis.
  • Systems programming: SCADA, PLC, HMI…
  • Setup of prevention plans.
  • Validation and monitoring of deliverables and timelines.
  • Regulatory watch: CFIA, FDA, Health Canada…
  • Staff training.
  • Multi-disciplinary collaboration.
Serialization

Facing an increase of counterfeit medicines, effective tracking devices must make it possible to identify products and certify their originality. Our consultants assist our partners in designing and implementing their traceability system.

  • Management of serialization projects.
  • Risk analysis: FMECA, QbD approach…
  • Commissioning, validation and periodic review.
  • SNMS system architecture.
  • Drafting of protocols and reports.
  • Creation of serialization models.
  • Creation of data maintenance models.
  • Drafting of SOPs and staff training.
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…

Quality & Regulation

Quality Assurance

We support life science companies and research institutes in terms of quality assurance, which is a financial, competitive and safety issue. We take into account the quality requirements specific to our partners, along with those of the market and regulations.

  • Management of quality assurance projects.
  • Document review: SOPs, protocols…
  • Review of Master Batch Records (MBR).
  • Drafting of the quality manual and APQR reviews.
  • Complaint management and definition of KPIs.
  • Quality investigations: Ishikawa, etc.
  • Staff training on procedures.
  • Drafting of deviations, CAPA, change control.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Regulatory Affairs

The constant change of regulatory guidelines forces companies to monitor them on a daily basis. Through the expertise of our specialists, we support our clients in ensuring that their activities and products comply with the various standards in force.

  • Regulatory management of pharmaceutical projects.
  • Drafting and review of regulatory documents.
  • Documents submission for marketing authorization.
  • Audit and drafting of SOPs related to regulations.
  • Review of promotional materials.
  • Development and update of product monographs.
  • Staff training on procedures and risks.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
Drug Safety

We advise and help our clients monitor, evaluate, prevent and manage the risks related to their drugs' adverse effects, before and after bringing them on the market.

  • Risk management related to adverse effects.
  • Collection and processing of raw data.
  • Declaration of adverse effects.
  • Safety data documentation and archiving.
  • Drafting of SOPs and staff training.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.

Clinical Research & Tests

Clinical Research

We are involved in all clinical research study activities, whether exploratory (to understand the biological mechanisms of a disease), pre-clinical (to test the effectiveness of treatments on animal models) or formulation (to develop the most appropriate formulation).

  • Remote and on-site monitoring of study sites.
  • Monitoring plan management.
  • Source data verification.
  • Adverse events verification.
  • Reports and investigation files verification.
  • Compliance of clinical study activities.
  • Identification of study improvements.
  • Registration of serious adverse effects.
  • On-site support and audit.
  • On-site patient recruitment strategy.
  • Regulatory watch: FDA, Health Canada, EMA, ICH…
  • Multi-disciplinary collaboration.
Clinical Tests

Our scientists are qualified to conduct clinical tests regarding drugs and treatments efficacy, safety and tolerance, according to strict protocols subject to regulatory supervision.

  • Support for the execution of clinical trial protocols.
  • Creation and maintenance of databases.
  • Creation and monitoring of Trial Master Files (TMFs).
  • Minutes and Non-Disclosure Agreements (NDAs).
  • Drafting of SOPs.
  • Multi-disciplinary collaboration.