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About
Royalmount Biopharma Services

01

Our Progression

Our parent company Pharmascience Inc. has developed strong roots in Canada, and is Quebec’s largest employer in the pharmaceutical field with over 1600 employees.

 

Royalmount CDMO has been operating out of the Candiac facility since 2014,
maintaining operations at this FDA-approved site. The facility’s capabilities have increased over time, progressing from development and manufacturing of small molecules to incorporating large molecules as well, such as Oligonucleotides, Monoclonal antibodies (mAbs) and Antibody-drug conjugates (ADCs).

 

Royalmount Labs external CRO business has become very successful, excelling in scientific excellence, customer service and on-time delivery. To accommodate the rapid growth, we continue to invest in the right staff, in the expansion and modernization of our laboratories, as well as in the latest technologies.

02

Where We Are Now

Pharmascience Inc. is currently Canada’s third largest generic pharmaceutical company.

 

Royalmount CDMO provides an extensive suite of services supporting drug
development from pre-clinical phases through to commercial supply. As one of the few FDA-approved facilities in North America with cytotoxic capabilities, our team is equipped to deliver solutions for vials, pre-filled syringes, and lyophilized products.

 

Royalmount Labs now employs over 60 scientific, technical and support staff, and occupies 10000 sq ft of purpose built laboratory and office space. We have the latest state-of-the-art instrumentation including LC-MS/MSs, MSD, multimode spectrophotometer plate readers, Luminex, qPCR, and robotic liquid handling systems.

 

As a partner of choice for many pharma, biotech and virtual companies, Royalmount Biopharma Services have a very high rate of repeat business, and this is a testament to our three core principles that we consistently deliver on to our clientele – Scientific Excellence; Customer Service; On-time Delivery.

03

Where We’re Going

Royalmount CDMO is completing an expansion that will triple its production capacity, enabling increased manufacturing of Vials, Pre-filled Syringes, and Lyophilized products for third-party clients. The CDMO continues to advance its capabilities with isolator vial line, automated visual inspection and integrated label, packaging, and cartoning technologies. Furthermore, the CMDO group consistently seeks to incorporate state-of-the-art equipment to further enhance its services and product offerings.

 

Royalmount Labs has ambitious growth plans for the next several years, including introducing new service offerings. We aim to become the leading niche small and large molecule bioanalytical CRO.

Quality standards

Quality, always on time

QUALITY ASSURANCE PROGRAM

Study-based inspections (study plan, in-process, study data and report for every study and validation); additionally perform regular facility-based and process-based inspections.

COMPLIANCE WITH INTERNATIONAL REGULATIONS

Strict adherence to Health Canada, EMA, and US FDA guidelines, ensuring the highest-quality procedures, data and reports.

STRINGENT QUALITY CONTROL

Quality Assurance / Compliance Internal Auditors functions as an independent Quality Assurance Unit. 

Quality Control / Data Review Team reviews 100% of raw data generated in the bioanalytical laboratories.

  • FDA audits in 2018 (onsite) and 2022 (virtual); no FDA 483 issued
  • GLP certified by Standards Council of Canada (SCC) since 2015; most recent re-certification in 2025
  • GCP inspected by Health Canada in 2018 and 2024
  • GMP inspected by Health Canada in 2020, 2022 and 2024

Bioanalytical Labs Customer Commitments

<10
Typically less than 10 days to start method development
40
40 Years of pharmaceutical operation
500+
500+ validated assays
450k+
450,000 samples analyzed each year
16
Clients from 16 different countries
16
16 mass spectrometers
20
Analysis in support of 20 studies per month

Regulatory Agencies

OUR FACILITIES

Laboratories Facilities

Our Montreal based GLP/GMP/GCP-compliant laboratories act as a key partner for numerous pharmaceutical and biotechnology companies. We adapt to the rapidly changing needs of our clients, overcoming the challenges related to regulated bioanalysis.

  • Over 60 dedicated professionals
  • 12 triple quadrupole mass specs including API 6500+ and 5000™
  • 250,000 bioanalytical samples analyzed per year
  • >500 validated assays available; extensive method development capabilities
  • 2 Shimadzu ICP-MS
  • 1 Meso Sector S 600MM (MSD)
  • 1 QuantStudio 7 qPCR
  • 2 Agilent microplate spectrophotometer readers
  • 1 Luminex
  • 2 Hamilton® STAR™
CDMO Facilities

Our CDMO facility is strategically situated just 30 minutes from the US border. The site’s agility enables us to collaborate effectively with clients to address their project requirements for vials, pre-filled syringes, and lyophilized products.

  • Franz Ziel Isolator
  • Bausch and Strobel Filler
  • GEA Lyophilizer
  • Automated visual inspection for Vial and PFS Formats
  • Automated label, packaging and cartoning technologies

Our team

Gabriel Zenker
Gabriel Zenker
General Manager, Royalmount Biopharma Services
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Peter Skoutelas
Peter Skoutelas
VP, Sales and marketing
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Adrien Musuku
Adrien Musuku
Senior Director, Biopharmaceutics
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John Chapdelaine
John Chapdelaine
Director, Business Development
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Renée Riffon
Renée Riffon
Director, Large Molecule Bioanalysis and Biomarkers
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Caroline Dubuc
Caroline Dubuc
Director Business Development
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Elia Nahas
Elia Nahas
Senior Manager, CDMO Operations
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Franco Reale
Franco Reale
Account Manager, BD and Strategic Alliances
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Aleksandra Isakovic
Aleksandra Isakovic
Marketing and Business Development Manager
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Cristina Tita
Cristina Tita
Finance Manager
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Our lab team

Weixing Sun
Weixing Sun
Director, Research and Development
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Hong Wong
Hong Wong
Manager & Principal PK Scientist
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Ying Zhao
Ying Zhao
Manager, Chemistry and Analytical Services
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Giuseppina Vinci
Giuseppina Vinci
Manager, Quality Services
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Samantha Samuels
Samantha Samuels
Manager, Bioanalytical Operations
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