Business Challenge? Meet the Expert.

The Evanston Group provides hand-picked, elite leadership and subject matter experts to help businesses solve their toughest problems. We start with your needs – not our methodologies or consultants..

Clients use us when they need a small to mid-sized team of highly-specialized leadership professionals—the kind that might cost 2 or 3 times the amount at a large, well-known integrator. They also use us when they need solid project managers with specific project backgrounds that can learn their environment quickly, manage by methodology and process, and meet challenging budget and time constraints. Below are the Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives.

Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Total Product Life Cycle (TPLC) from initial concept to product retirement
  • Cross-functional and Clinical leadership (Phases 1 – 4)
  • R&D PMO Tools and Processes
  • Clinical Trial design, management, and data management (CTMS)
  • Clinical Compliance: Sites, Protocols, Study Reports
  • Pipeline & Portfolio Management
  • Therapeutic Area (TA) Subject Matter Experts including study physicians scientists, Medical monitors, and principle & reliability engineers
  • Combination devices and software interactions
  • Benchmarking Strategy & Analysis
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Submissions & Approvals
    • Drug: IND, A/NDA, BLA, CBE, DMF Amendment, EMA
    • Device: IDE, 510(k), PMA, CE Marking Design Dossiers/Technical Files
  • Regulatory Subject Matter Experts & Strategists including specific approval pathway consulting
  • Licensing, Packaging, and Labeling Approvals
  • Technical Transfers, CMC, & new manufacturing site documentations and submissions
  • Life Cycle Management
  • Remediation Projects
  • Site & Documentation Audits
  • FDA Liaison
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Separation/Merger/Divestiture Planning & Transformation
  • Master Data, Records, and Document Management
  • Transitional Service Agreements (TSAs)
  • Process/SOP Integration & Alignment
  • Renaming and labeling changes
  • Organizational Change Management & Training
  • Sales and Reporting Integration
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Tech Transfers
  • Site Separation and Relocation
  • Product Expansion and Launch
  • Chemical, Manufacturing, and Controls (CMC)
  • Supplier Quality
  • Supply Chain Sourcing
  • New Manufacturing Plants
  • Raw Materials & API Development
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • 483 Responses
  • Warning Letter & Consent Decree prevention/remediation
  • Remediation
    • Design History Files
    • Device Master Records
    • Drug Master Files
    • Risk Management
    • CAPA and Adverse Events (AE)
    • Document Control including Labeling
  • Complaint management & complaint systems
  • Quality Systems
  • Supplier Quality assessments, relationship management, and remediation
  • GXP Consultants: GMP, GLP, GCP
  • Quality and Reliability engineers
  • 3rd Party Experts
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Affairs Strategy & Operations
  • Organizational Change Management, Communications & Training
  • Therapeutic Area (TA) and Disease specific support including physicians/scientists and medical monitors
  • Pharmacovigilance and Medical Safety
  • Compliance Operations
  • Product Launch Strategy & Support
  • Key Opinion Leader (KOL) Facilitation and Management
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Product Launch
    • Strategy
    • Processes and Improvements
    • Training
    • Execution
  • Commercial Strategy & Optimization
  • Product expansion into new global markets
  • Promotions and Product Labeling
  • LCM (Life Cycle Management) & Product Defense
  • Global Medical Communications and Event Management
  • Acquisition and Divestiture logistics
  • Insights and Analytics
  • Market Research and Analytics
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • PMO Creation and Process Development
  • PMO/PPM Tool Implementation and Adoption
  • Portfolio Management
  • PMO Maturity level assessments, strategy, and improvement
  • Resource and Demand Management
  • Communication and Training
  • Dashboard design and creation
Project/Program Leaders and Subject Matter/Technical Experts competencies on the following types of initiatives:

  • Global Software Implementations (ERP, PLM, CRO, PPM, etc)
  • Integration & Separation Activities
  • Business and Functional Analysis
  • Business, Enterprise, and Solution Architecture
  • Data Management
  • Interim Leadership