
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