PBE Expert Français

Facilities built
to inspire
confidence.

From first drawing to certification, PBE Expert designs, builds and qualifies facilities approved by the FDA, the EMA and Health Canada.

See our projectsTalk to an Expert

Aseptic vial filling in an isolator, a gowned operator behind the barrier

Your contamination control strategy, designed, implemented and demonstrated all the way to inspection.

EMA-Annex 1 

EMA-Annex 1 and regulatory compliance

Ready for inspection.

  • EMA-Annex 1

    Our specialty, from design to inspection

  • FDAUnited States
  • Health CanadaCanada
  • ANSMFrance
  • ISO 14644Cleanrooms
  • ASME BPEBioprocessing equipment
  • ICH Q9Quality risk management
  • GAMP 5Computerized systems
  • USP 797Sterile compounding

Our signature

From EMA-Annex 1 compliance to excellence in sterility assurance.

Discover our method

Trusted by

Based on your situation

What expertise do you need?

Testimonials

Hear it from our clients.

ATLASPharm

In PBE, we have found all the scientific and regulatory expertise any pharmaceutical plant needs to meet the highest levels of compliance.

Client
MSH Pharma

PBE is a partner for us and we are counting on you to support us in carrying out our projects and our growth.

Jafaar Z.President, MSH Pharma
Pharmascience

Thank you so much for your excellent work.

Theodore N.Supervisor, Investigations (Operations), Pharmascience
Cryopak

It was my pleasure to attend the training with your team yesterday. I appreciate the update regarding the signed certificates and the presentations. Your team’s professionalism and expertise at PBE Expert are greatly valued, and I’m glad to have the opportunity to work with you.

Jalal BelbalDirector of Quality and Services (CVT), Cryopak
Vetio Animal Health

I would like to thank you all for the work you have done, it is very well done. Thanks in advance.

Camilo Z.Validation Manager, Vetio Animal Health
CIPE

Excellent training. It met my expectations exactly. Aziz did a very good job. He doesn’t just present the material; he gets us involved and challenges us.

Mr. LarivièreParticipant, CIPE FormAction™
CIPE

Trainer’s qualifications and experience: excellent. Presentation skills: excellent.

Mr. Thibeault and Ms. DeMontignyParticipants, CIPE FormAction™

  1. 01 / 05Pharmaceutical engineering

    In every capsule,
    an entire plant.

  2. 02 / 05Processes and clean utilities

    Precision starts
    long before production.

  3. 03 / 05Cleanrooms and disinfection

    Every parameter counts.

  4. 04 / 05Production and quality control

    Every step is verified.

  5. 05 / 05Laboratory, validation and quality assurance

    EMA-Annex 1 compliance is built in.

PBE Expert

GMP engineering, validation and compliance
for the healthcare industries.

Talk to an ExpertSee our expertise

In every capsule, an entire plant

What we do

From design to Annex 1 compliance.

Our eight services

Industries we serve

Where EMA-Annex 1 compliance is non-negotiable.

From solid dosage forms to injectables, from vaccines to hospital compounding: we know the specific requirements of every regulated industry.

Our projects

Engineering in the service of life.

  • Vaccines

    Moderna: C&Q and quality assurance for a sterile vaccine

    The PBE Expert team qualified the manufacturing equipment, clean utilities and HVAC for sterile bulk mRNA vaccine production…

    Read the case study : Moderna

  • Women’s health

    Endoceutics: a vaginal ovule unit for women’s health

    Designed, built and qualified inside a plant already in operation, and approved by the FDA, the EMA and Health Canada…

    Read the case study : Endoceutics

Our team

The experts behind your projects.

Meet the team

  • Facilities that pass
    EMA-Annex 1 inspection.

    Our projects
  • 300+EPCMV projects completed

  • 35+

    years of combined experience among our experts

  • 4continents

    • North America
    • Europe
    • Africa
    • Middle East

International presence

From Montreal, across four continents.

Our head office is in Montreal, with offices in Beloeil, Tampa, Casablanca and Constantine. Our experts work with manufacturers and health organizations across North America, Africa, Europe and the Middle East.

A sterile facility isn’t tested at the end: it’s designed, qualified and proven, from the very first drawing.

Resources

Guides, videos and lessons from the field.

All our resources

FormAction™ and events

Sharing expertise, training the next generation.

All FormAction™ courses

Careers

Join our GMP Experts.

Process engineers, validation specialists, quality experts: join a team that delivers compliant facilities on four continents.

See careers

Keep exploringAboutSince 2012, PBE Expert’s engineers, validation specialists and quality experts have been working for the healthcare industries.

See alsoExpertiseAnnex 1

Did you spot the error?
If not, talk to an Expert.

Talk to an Expert

A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.

Spot the error in this aseptic plantEMA-Annex 1

Sheet 1 of 1 · Rev. 0
QC lab Gowning · airlockGrade D · +15 Pa Clean utilitiesTechnical area PreparationGrade C · +30 Pa AirlockGrade B AsepticfillingA/B · +45 Pa Your project starts here
PBE Expert
Engineering · Validation · GMP compliance
Project
Yours · No. PBE‑A1‑2026
Standards
EMA-Annex 1 · cGMP · ISO 14644 · ASME BPE
Head office
9200 Meilleur Street, Suite 301
Montréal, QC H2N 2A9
Approved by
The PBE Expert team