Data/Information Governance & Strategy
  • Leverage data to improve processes
  • Transition from data to actionable insights
  • Create dynamic data models that are easy to sustain
  • Increase compliance through visibility into tangible metrics
  • Improve regulatory intelligence through learning and data sharing
  • Turn static data into actionable triggers
  • Reduce costs by eliminating data redundancy, commodity tasks, and variations
  • Compliance with increased data reporting requirements
  • Registration, submission, correspondence, and commitment tracking
  • Cross-functional data/information governance and management
Global Labeling & Regulatory Strategy

One-Stop Shop for all Global Labeling and Regulatory Strategy Services

  • Efficient global labeling process that enables monitoring, tracking, and reporting of labels from creation of the company core data sheet to implementation to local labels and finally hand-off for artwork.
  • New legislation
    • eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)
    • Identification of Medicinal Products (IDMP)
  • Organization
    • Governance
    • Process
    • Training
    • FTE analysis
    • Organization structure
    • Design and optimization
  • Labeling operations
    • Structured Product Labeling (SPL) management of drug listings data and document migration/management
  • Labeling strategy
    • Full outsource global labeling support for label management
    • Drug development and post-marketing labeling strategy
  • Compliance
    • Metrics
    • Tracking
    • Reporting
    • Standards
    • Templates
    • Global regulations/policies
Technical PM (eg, Labeling, Submissions)

Pyxa Provides Technical Project and Program Management to Ensure Accurate and Quality Deliverables

  • Best practice
  • Gap analysis
  • System implementation
  • Process
  • Product strategy
  • Label alignment
  • Standards
Product Development & Planning

Leading Global R&D Product Strategy

  • Acquisition
  • Global Dossier Strategy
  • Core submission package
    • Simultaneous and strategic global filings
  • Post-marketing
    • New markets
    • Registration management
    • Promotional materials management
    • Iterations, new indications, label updates, and CMC changes
  • IND/CTA and marketing applications
    • IB, protocol, CSRs and clinical summaries
    • Pre-clinical reports and summaries
  • Pre-IND/CTA
    • Briefing document, scientific advice, and global filing
    • Strategies
Risk Management & Compliance

Strategic and Cost-Effective Organizations

  • Pyxa’s broad and diverse range of services enhance compliance and aid in risk management and mitigation
  • Developing policies or SOPs within a function or cross-functionally
  • Communicating, implementing, and training functions on new regulations
  • Foundational risk management assessments
  • Developing and implementing compliance and value tracking and reporting
  • Closed-loop between change control and regulatory submissions
Information Management
  • A deep understanding of the information flows between Regulatory Affairs and other functional areas
  • A unique holistic view of processes, data, and requirements
  • EVMPD
  • eCTD
  • IDMP
  • RIM strategy and implementation
  • Business process-based application
  • Multi-functional approach
  • Data simplification
  • Challenge IT complexity
  • Connect information flows
  • Shared services for routine activities