Project & Program Management

• 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

Quality

• 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)​

Research & Development

• 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

Regulatory

• 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

Medical Affairs

• Health Economics & Outcomes Research (HEOR)

• Compliance

• Pharmacovigilance

• Medical Safety

• Medical Liaisons

• Information Services

• Communications

• Education

Information Technology

• 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 & Marketing

• Sales Strategy

• Speaker Program Management

• New Channel Development

• Operational Efficiency

• Product Marketing

• Market Technology Review & Assessment