Capabilities

Types of Roles

  • Program & Project Planning

  • Resource Allocation & Management

  • Budget Establishment, Analysis & Tracking

  • Project Scope Definition

  • Mergers, Acquisitions & Divestitures

  • Functional Leaders & Team Members

  • Success Measures & Metrics (Dashboards)

  • Assessments

  • Deviation & CAPA Management

  • Drug Quality & Security Act (DQSA)

  • Drug Safety

  • Process Design, Harmonization & Validation

  • QA/QC

  • Remediation Services

  • Unique Device Identification (UDI)

  • Design History File (DHF), Drug Master File (DMF) & Device Master Record (DMR)​

  • Clinical Trial Phases I-IV

  • Product Development Process

  • Total Quality by Design

  • Drug Formulation

  • Drug Delivery

  • Drug Stability

  • Process Development

  • Design Controls

  • Pipeline & Portfolio Management

  • Risk Management

  • FDA & EU (483 Observations, Warning Letters, Consent Decrees) Remediation

  • Submissions (Premarket Approval PMA, 510(k), CE Mark, INDs, ANDAs) & Compliance

  • Technical File & Design Dossier Preparation

  • Labeling, Packaging, Advertising & Promotional Materials

  • Health Economics & Outcomes Research (HEOR)

  • Compliance

  • Pharmacovigilance

  • Medical Safety

  • Medical Liaisons

  • Information Services

  • Communications

  • Education

  • Business Intelligence

  • Change Management

  • Customer Relationship Management

  • Enterprise Document Management System

  • Electronic Laboratory Notebook

  • ERP (SAP, Oracle)

  • Laboratory Information Management Systems​

  • Manufacturing Execution System

  • PMO & PPM

  • Quality Management System

  • Operations & Manufacturing Strategy and Process Excellence

  • Technical Transfer

  • Innovation & Product Development

  • Sourcing and Procurement

  • Integrated Planning & Analytics, Logistics, Quality and Supplier Compliance

  • Knowledge Capital

  • Implementation Accelerators

  • Analytics & Mobility

  • Control Towers

  • Contract Manufacturing

  • Six Sigma

  • TPM

  • Sales Strategy

  • Speaker Program Management

  • New Channel Development

  • Operational Efficiency

  • Product Marketing

  • Market Technology Review & Assessment

312.424.0500
205 W. Wacker Drive, Suite 515, Chicago IL 60606
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