Expert Network2018-07-13T15:42:35+00:00

The Expert Network

Trusted Professional Service Providers

Montrium has engaged with the top professional services firms and independent consultants to provide a total package to our clients. The Expert Network Partners below are some of the most professional, responsible, and knowledgeable experts in our area, and share Montrium’s vision of advancing therapeutical areas through the advancement and implementation of technology.

Whether its auditing services, computer system validation (CSV) or cloud compliance, our team and our extended expert network have the experience, knowledge and skills to help your organization.

We are always seeking new experts to join our network – if you believe your expertise can benefit our life sciences clients please visit contact us.

Need help looking for an Expert?

Speak to our team

Our Expert Network Partners

Our Expert Network consists of experienced industry consultants and organizations with a deep understanding of the life science industry. The expert network team provides a wide range of high-quality compliance and technology services to our life sciences clients globally.

Contact for Services

Bethan Rider

GxP Quality & Compliance Auditor – Calgary, AB

Computer System Validation | GxP Document Review | Pre-Audit Preparation

ASQ Certified Quality Auditor since December 2010 (re-certified December 2013). Regularly performs supplier audits on the behalf of multinational Pharmaceutical companies including API, Medical Devices, Contract Manufacturers, Re-packagers and Excipient Manufacturers.

  • Vendor Auditing / Due Dilligence
  • Regulatory Agency Pre-Audit Preparation
  • Quality Assurance as a Service (QaaS)
  • Quality Managment System / SOP Development
  • CAPA Review
  • HACCP Plan & Review
  • 21 CFR Part 11
  • User Requirements Gathering
  • ASQ Certified Quality Auditor since December 2010 (re-certified December 2013)
    BSc (Hons) in Chemistry with Pharmaceutical and Forensic Sciences – University of Bradford, England, UK
  • Canada
  • United States
  • Europe
Contact for Services

Jean Morin

Business Process & Technology Integration Specialist – Montreal, QC

GxP System Integration | GxP Initiative Transformation | GxP System Implementation

Extensive document management and workflow experience.  Strong background and ability to quickly understand the big picture, develop strategies to implement/modify the operational plan and communication skills to ascertain and satisfy the divergent needs of the business units.  Strong analytical and interpersonal skills allows Jean to drive transformational initiatives with confidence.

  • Vendor Auditing / Due Dilligence
  • Regulatory Agency Pre-Audit Preparation
  • Quality Assurance as a Service (QaaS)
  • Quality Managment System / SOP Development
  • CAPA Review
  • HACCP Plan & Review
  • 21 CFR Part 11
  • User Requirements Gathering
  • Canada
  • United States
  • Europe
  • Asia
  • French
  • English
Contact for Services

Dierk Schmidt

Project Management and R&D Systems Consultant – Frankfurt, Germany

Project Management | Business Process Engineering | Quality Assurance

Dierk Schmidt is an independent Consultant and Project Manager with more than 20 years experience in Clinical R&D. After studying mathematics and computer sciences, Dierk joined the pharmaceutical industry as a Biometrician. Throughout his career in Pharma (Takeda, Astellas) and Contract Research Organizations (e.g. PRA, PAREXEL), he has gained significant cross-functional experience in heading up Biostats, Programming, Data Management, Clinical IT and infrastructure groups in Europe, US and Japan.

Over time, Dierk has specialized in Project Management and consultancy for R&D infrastructure projects and established a significant track record of leading global, cross-functional system implementation projects.

  • Project Management
  • Business process analysis and SOP development
  • System audits and CAPA remediation
  • Vendor audits and due diligence
  • Regulatory agency pre-inspection preparation
  • Computer system validation
  • Clinical Data Management and Biostatistical Services (incl. SAS Programming)
  • Canada
  • United States
  • Europe
  • German
  • English
Contact for Services

Comes Compliance Services (CCS)

Pharmaceutical Regulatory Compliance Services – Ravensburg, Germany

Quality Management | Computer System Validation | Pharmaceutical Compliance

comes compliance services is a highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At comes compliance services (CCS), they strongly believe that quality and compliance management will drive continuous improvement and performance optimization. CSS utilize a more proactive and risk-based approach to quality assurance and validation backed by proven expertise and electronic tools from our partners.
  • Quality System /PQS Integration
  • Corrective and Preventive Action
  • GxP Data Integration and Governance
  • Audits and Inspections Managament
  • Computer System Validation
  • Annex 11 and 21 CFR Part 11
  • Software Development Life Cycle
  • Project Management
  • Infrastructure Qualification
  • Logical Security
  • Canada
  • United States
  • Europe
  • Asia
  • German
  • English
Contact for Services

LMK Consulting

Clinical Research Consulting

TMF Management & Processing | Strategic Consulting | Quality Control Solutions

LMK Clinical Research Consulting, LLC (LMK), is a global Functional Service Provider of Trial Master File (TMF) consulting and TMF services. LMK specializes in the strategic development, project management and quality control of documents and content that support clinical development. From study start through completion, our TMF experts deliver quality document management and TMF solutions to ensure your TMF is inspection-ready at all times.

Areas of Expertise

  • TMF Planning
  • TMF Training
  • TMF Maintenance
  • TMF Quality Control
  • TMF Closeout
  • TMF Migration
  • “ Women’s Business Enterprise National Council (WBENC) “
  • “Small Business Association (SBA)”
  • “Metrics Champion Consortium (MCC)”
  • “National Association of Professional Women (NAPW)”
  • “Charlotte Chamber Of Commerce”
  • Canada
  • United States
  • Europe
Contact for Services

Mark Choe

Trial Master File Inspection Preparation Expert

Agency Inspetion Preparation | TMF Quality Management | TMF Build, Resourcing and Vendor Management

Mark has two decades of experience in drug development with a wide scope of responsibility from clinical operations to agency audit preparations and response. Using his in-depth knowledge of the industry, he provides his clients with access to advanced business solutions.

Mark has experience with regulated electronic systems across the entire spectrum, with involvement in vendor audits, business analuysis, design and validation of EDMS systems, EDC, CTMS systems, eCTD platforms and eTMF solutions.

Areas of Expertise

  • Regulatory agency pre-audit preparation
  • Audit finding remediation
  • Quality Management System / SOP Development
  • GxP document review
  • TMF Management
  • CRO Vendor Selection
  • Clinical Trial Document QC
  • Clinical Trial SOP Development
  • 21 CFRPart 11 compliance assesment
  • Responsible TMF for two compounds passed FDA inspections
  • Expert in current eTMF technology and application of TMF reference model
  • Expert in Quality Management of TMF
  • Audit and CAPA experience
  • Operational expertise in vendor management, clinical, SOP and compliance
  • New Jersey
  • New York
  • Connecticut
  • Pennsylvania
  • Toronto
  • Ontario
Contact for Services

P3Life Consulting

Project Management & Compliance Consulting

Project Management | Software Development | Computer System Validation

P3Life is a consulting firm whose value proposition is to increase the performance of Life Sciences organizations’ projects and processes through increased maturity in project management and business process efficiency by deploying content management and collaboration solutions.

Areas of Expertise

  • Project Management, Standard and Agile
  • Software Solution Selection
  • SharePoint solutions development
  • Computer system Validation
  • Portuguese
  • Spanish
  • English
  • Latin America

Sign up to our newsletter

Receive weekly updates from our blog, webinars and free resources!

Visit our blog or free resources now!