Our team

 

Montrium GXP Consulting makes the difference by offering a wide range of services covering all aspects of GxP  regulatory compliance independently from the Sponsors/MAHs and their vendors, with a group of international multilingual auditors that served in the USA, Europe, Canada, Latin America, Middle East and Asia in the following sectors: pharmaceuticals, biologics and medical devices, pharmaceutical manufacturing, distribution, pre-clinical studies, clinical trials, laboratory testing, pharmacovigilance, quality assurance and regulatory affairs.

With auditors based in Europe, USA and Canada, we can support your R&D projects in both North America and Europe. Our team is composed of more than 10 highly qualified auditors with an extensive experience in Quality Assurance between 12 and 30 years. Our Lead Auditors have all assisted our Clients successfully in Pre-Approval Inspections (FDA, EMA, Health Canada) and we have conducted more than 2000 audits in over 50 countries worldwide. In addition, language capabilities in this group currently include: English, French, German, Greek, Hindi, Italian, Spanish and Portuguese.


Montrium GXP Consulting was founded in 2001 by Christophe Barcella, M.Sc.Pharm.Eng., president and lead GxP auditor. With a strong academic background in pharmaceutical sciences and quality management, Christophe Barcella has gained an extensive international auditing experience of over 28 years in GxP compliance. Fully knowledgeable in ICH, EMA, FDA and Health Canada regulations & directives, Christophe has conducted over 700 audits in a multitude of therapeutic areas for various products, both Investigational and Commercial (drugs, biologics, peptides and vaccines). Prior to becoming a full-time GxP consultant and auditor, Christophe occupied various senior management positions in Clinical Quality Assurance and Regulatory in the Pharmaceutical Industry, including CROs (Quintiles), Academic Groups (Breast Cancer International Research Group), Biotech Companies (Aeterna Zentaris). Previous experience also includes having worked as Pharmaceutical Quality Control Lead in manufacturing and laboratories (GSK, Sanofi-Pasteur). In addition to providing training and QMS support, Christophe has performed audits in GCP (over 270), GLP & GCLP (over 160), GVP (over 90), GMP & GDP (over 190) worldwide.



Montrium GXP Consulting has an extensive experience with the following types of medicinal products and therapeutic areas:

 

  • Types of medicinal products: drugs, biologics, monoclonal antibodies, peptides, vaccines, gene therapy, medical devices, in-vitro diagnostics devices, consumer products.
  • Therapeutic area experience: oncology, internal medicine, cardiovascular, CNS, GI, anti-infectives, ophtalmology, immunology, dermatology, etc.

Our CVs are available upon request.

 GXP consulting network