Staff in cleanroom garments in a production unit

Projects

More than 300 projects
seen through to completion.

Since 2012, pharmaceutical manufacturers, biotechs and public health organizations have trusted us to design, build and qualify their facilities.

A smiling grandmother hugging her granddaughter

Women’s health

One menopause drug,
three inspections passed.

With Endoceutics, the PBE Expert team installed a vaginal ovule production line that passed FDA, EMA and Health Canada inspections.

For women
Vaginal suppositories for the symptoms of menopause: regulating the estrogen imbalance, relieving local discomfort and pain, and improving overall well-being.
A highly potent hormone
Vaginal ovules with an OEL 3 active ingredient, in Mont-Saint-Hilaire, Quebec.
From start to finish
From compliance audit to pre-approval inspection: design, process engineering, construction and validation, on an EPCMV basis.

3inspections passed: FDA, EMA and Health Canada

View project

Projects

Projects that passed inspection.

From design to approval by the FDA, EMA and Health Canada: a selection of projects led by PBE Expert in Canada, Europe and North Africa.

Pharmaceutical Mont-Saint-Hilaire, Quebec · 2016–2020

Endoceutics: a vaginal ovule unit for women’s health

For Endoceutics, PBE Expert designed, built and qualified the new production unit for Intrarosa, a treatment for menopause symptoms, inside a plant already operating in Mont‑Saint‑Hilaire.

Read the case study

Compliant, sterile, contained and approved facilities, from blueprint to inspection.

BuildA vaginal ovule production unitMont‑Saint‑Hilaire · approved by the FDA, EMA and Health CanadaView project BuildA sterile vaccine facility with BSL-2 containmentMontreal · approved by the FDA and EMAView project BuildA contained biotechnology production unitSwitzerland · approved by the FDA and EMAView project BuildHighly potent oncology injectablesFrance · approved by the FDA and EMAView project

Project portfolio

Real clients, real results.

A selection of engagements carried out by the PBE Expert team, organized by area: the client, the facility, the regulators and the work done.

300+EPCMV projects completed
100+pharmaceutical, biotechnology and life sciences clients

From start to finish
Concept, layout and URS through to C&Q and inspection readiness: not just one phase of the project.
Sterility and containment
Isolators, RABS, GMP cleanrooms, OEL 5 and above, BSL-2 and BSL-3 facilities.
Regulators worldwide
FDA, EU GMP and EMA, Health Canada, WHO, PIC/S.

PBE-P-01
Moderna
Montreal, Canada · 2024

Sterile and aseptic
Bulk sterile vaccine · C&Q and quality assurance
IOQ of manufacturing equipment, clean utilities and HVAC; quality assurance; procedure writing; risk analysis.
- FDA
- EMA
- Health Canada
PBE-P-02
Jubilant Pharma
Montreal, Canada · 2022–2024

Sterile and aseptic
Sterile injectables, fill and finish
EMA-Annex 1 compliance for the facility and HVAC: gap analysis and remediation of the HVAC, HEPA filters and pure steam generator; risk analysis.
- FDA
- EMA
- Health Canada
PBE-P-03
Delpharm and Steri-Med
Montreal, Canada · 2021–2023

Sterile and aseptic
Sterile injectables, vial fill and finish
Quality assurance and C&Q: IOQ of the label printer and secondary packaging equipment, IQ and OQ of the purified water system, risk analysis, and upgraded procedures for the testing laboratories.
- FDA
- Health Canada
PBE-P-04
Institut Pasteur de Dakar
Dakar, Senegal · 2021–2027

Sterile and aseptic
Sterile vaccine
URS, traceability matrix, DQ, risk analysis and C&Q (IQ, OQ) of the clean utilities (water for injection, clean compressed air), HVAC, cleanroom finishes, cold rooms, laminar airflow units, biosafety cabinets, and sterilization and decontamination autoclaves.
- FDA
- EMA
- Health Canada
PBE-P-05
International pharmaceutical manufacturer
France
Total cost€11M

Major European projects
HP3 oncology injectables unit
Revamp of an HP3 oncology injectables production unit to SafeBridge standards: freeze-drying, clean-in-place, laminar airflow, PW, PS, VHP and isolators; clean utilities (steam, compressed air, nitrogen, acetone); purified water and effluent treatment; cleanroom HVAC.
View project: International pharmaceutical manufacturer
- FDA
- EMA
PBE-P-06
Biopharmaceutical company
Switzerland
Total costCHF 59M

Major European projects
Contained biotechnology production unit
Engineering and project management: 4,000 m² of ISO Class 7 and 8 cleanrooms with level 2 containment, 1,500 m² of technical space, 2,000 kVA of power, two steam boilers and full clean utility generation.
View project: Biopharmaceutical company
- FDA
- EMA
PBE-P-07
International medical device manufacturer
France · 2007–2008
Total cost€8.5M

Major European projects
Cleanrooms and production building
Expansion of cleanrooms and pharmaceutical environments (700 m² of ISO Class 5 and 6 cleanrooms, €6 million) and construction of a 4,000 m² production building with offices (€2.5 million); utility validation and qualification.
View project: International medical device manufacturer
- EMA
PBE-P-08
Institut Pasteur de Dakar · Vaccinopole
Dakar, Senegal · 2024–2025

Vaccines, biologics and plasma
New vaccine production site
Turnkey layout, URS, traceability matrix, risk analysis, design qualification and drafting of the IQ and OQ documents: HVAC, compressed air, cleanrooms and interlock systems.
- EU GMP
PBE-P-09
GreenCross and Bosch
Montreal, Canada · 2016–2018

Vaccines, biologics and plasma
Blood plasma fractionation
Design review and GMP-compliant design of the thawing and pooling skids and the clean utilities (pure steam, purified water, water for injection); FAT, SAT, IQ and OQ protocols; traceability matrix; on-site installation supervision.
View project: GreenCross and Bosch
- FDA
PBE-P-10
Vaccine project in Switzerland
Switzerland · 2001–2004

Vaccines, biologics and plasma
New vaccine production site
Turnkey layout, URS, traceability matrix, risk analysis, design qualification and drafting of the IQ and OQ documents: HVAC, compressed air, cleanrooms and interlock systems.
- EU GMP
PBE-P-11
University genomics research center
Montreal, Canada

Vaccines, biologics and plasma
Construction of a research facility
Layout and project services for construction; selection and bid analysis for the purified water system, washer and sterilization equipment.
PBE-P-12
PurLab
Oran, Algeria · 2018–2024

Oncology and containment
Oncology: solid dosage forms, injectables and a cytotoxic biosimilar
Facility delivered on an EPCMV basis for oncology oral solid dosage forms, oncology injectables (OEL 5, vial fill and finish) and a cytotoxic biosimilar (OEL 5, vials, prefilled syringes, cartridges): GMP-compliant layout, conceptual and basic engineering, detailed URS and FDS, modular cleanrooms, HVAC, containment equipment, clean utilities, shop drawing approval, installation and commissioning, VMP, C&Q and computerized system validation, pre-approval inspection (PAI) support.
View project: PurLab
- EMA
- WHO
PBE-P-13
Isologic
Montreal, Canada · 2021–2022

Oncology and containment
Sterile radiopharmaceutical injectables
C&Q: IOQ of the manufacturing equipment, containment isolator and HVAC; risk analysis.
- FDA
- EMA
- Health Canada
PBE-P-14
Medicago
Quebec, Canada · 2021–2022

Oncology and containment
Sterile injectable vaccine, fill and finish
C&Q: IOQ of the manufacturing equipment and HVAC, sterile filtration validation, risk analysis, process and cleaning validation, Validation Master Plan.
- FDA
- EMA
- Health Canada
PBE-P-15
MedXL
Montreal, Canada · 2021–2023

Oncology and containment
Sterile injectable medical device
C&Q: IOQ of the sterile formulation and prefilled syringe filling equipment, secondary packaging equipment and HVAC; risk analysis; process and cleaning validation; Validation Master Plan.
- FDA
- Health Canada
PBE-P-16
International pharmaceutical manufacturer
France
Total cost€10M

Oncology and containment
New oncology solid dosage plant (OEL 5+)
New plant for highly potent oncology oral solid dosage forms (OEL 5 and above), with full-body protective suits as the PPE for containment.
View project: International pharmaceutical manufacturer
- FDA
- EMA
PBE-P-17
Endoceutics
Mont-Saint-Hilaire, Quebec · 2016–2020, in several phases

Oral dosage forms and hormones
Vaginal ovules (OEL 3) · women’s health
EPCMV: compliance audit, conceptual and basic engineering, detailed design, process, URS and FDS, containment engineering, modular cleanrooms, HVAC and layout, clean utilities, installation, commissioning, quality assurance and Validation Master Plan, pre-approval inspection support.
View project: Endoceutics
- FDA
- EMA
- Health Canada
PBE-P-18
Pharmaghreb
Tunis, Tunisia · 2015–2016

Oral dosage forms and hormones
Hormonal solid dosage forms (OEL 5)
Compliance audit, design review and gap analysis, feasibility studies, root cause analysis, on-site troubleshooting, basic engineering, modular cleanrooms and HVAC, GMP FormAction™.
View project: Pharmaghreb
- FDA
- WHO
- EMA
PBE-P-19
Medicef (Hikma) and Medis
Tunis, Tunisia · 2014–2015

Oral dosage forms and hormones
Cephalosporins and oncology solid dosage forms
Cephalosporins (beta-lactams) and oncology oral solid dosage forms: GMP compliance audit, design review, feasibility studies, gap and risk analysis, layout redesign, containment technologies, GMP FormAction™.
- FDA
- WHO
- EMA
PBE-P-20
Duchesnay and two European pharmaceutical manufacturers
Canada and Europe

Oral dosage forms and hormones
Turnkey oral solid dosage lines
Turnkey lines with in-bin containment: dispensing, bin blender, mill, roller compactor, tablet press, coating, printing, blister packaging and secondary packaging, plus the clean utilities and HVAC.
- FDA
- EMA
- Health Canada
PBE-P-21
Prodoc, Zenith Pharma and a French pharmaceutical manufacturer
Canada, Morocco and France · 2007–2014

Oral dosage forms and hormones
Solid, suppository and liquid dosage forms
Compliance audit, design review, feasibility studies, gap and root cause analysis, EPCM qualification, GMP FormAction™.
View project: Prodoc, Zenith Pharma and a French pharmaceutical manufacturer
- FDA
- EMA
PBE-P-22
Silicycle
Since 2021

Compliance, audit and PAI
GMP compliance
GMP compliance, audit and pre-approval inspection readiness to meet FDA requirements.
- FDA
PBE-P-23
Getinge
Since 2022

Compliance, audit and PAI
GMP compliance and training
GMP compliance, audit, pre-approval inspection readiness and FormAction™, to ASME-BPE and FDA requirements.
- FDA
PBE-P-24
Multinational pharmaceutical company
2011–2012

Compliance, audit and PAI
Warehouse upgrade
Fire protection, floors and dynamic loads, HVAC, on-site construction monitoring.
PBE-P-25
Galderma
2011

Compliance, audit and PAI
8 m³ and 16 m³ mixing skids
Compliance audit, layout and process engineering.
PBE-P-26
Church & Dwight and Groupe Parima
2011

Compliance, audit and PAI
Liquid and ethanol-based forms
Layout and design review, explosion risk analysis (ATEX, NFPA, CSA).
PBE-P-27
Gasco Goodhue St-Germain and McKesson
2013

Compliance, audit and PAI
Cold room and warehouse
Audit of a cold room and a warehouse, supported by an expert witness.
PBE-P-28
Vetoquinol
2020

Compliance, audit and PAI
Computerized system validation
Computerized system validation, product risk analysis and mitigation.
- Canadian GMP
PBE-P-29
Atlas Pharma and Procepack
2021

Compliance, audit and PAI
ISO 17025 certification and C&Q
ISO 17025 certification, commissioning and qualification to FDA and Health Canada GMP.
- FDA
- Health Canada
PBE-P-30
MedXL
Since 2021

Validation, C&Q and computerized systems
Validation for new product integration
Validation project management for new product integration; qualification of critical equipment and utilities (protocols, execution, deviation resolution); process validation.
- Health Canada
- ISO 14644
PBE-P-31
Sterinova

Validation, C&Q and computerized systems
Facility validation
Facility validation.
PBE-P-32
Delpharm (Sandoz)
2020 à 2022

Validation, C&Q and computerized systems
Qualification and computerized system validation
Design qualification, validation plan, IOQ, packaging and computerized system validation: manufacturing tanks, filter integrity testers, sterile vial filling lines, vial labeling and visual inspection.
PBE-P-33
Hikma Pharmaceuticals
2004 à 2016

Validation, C&Q and computerized systems
Validation leadership, 12 years
Site Validation Master Plan; IQ, OQ and PQ of HVAC, water and compressed air; cleaning and process validation; data integrity protocols (HPLC); computerized system validation to 21 CFR Part 11.
PBE-P-34
Corealis Pharma, JD Edwards (Oracle) and Empower (Waters)
Multi-year programs

Validation, C&Q and computerized systems
Computerized system validation
Full validation of the ERP and chromatography data servers: validation plan, risk analysis, function classification, infrastructure qualification, audit trails, OQ and PQ.