STRATEGIC SERVICES

Data/Information Governance & Strategy

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  • 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 & variations
  • Compliance with increased data reporting requirements
  • Registration, submission, correspondence & commitment tracking
  • Cross-functional data/information governance and management

Product Development & Planning

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Leading Global R&D Product Strategy

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

Global Labeling & Regulatory Strategy

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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 through 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
  • Complaince
    • Metrics
    • Tracking
    • Reporting
    • Standards
    • Templates
    • Global regulations/policies

Risk Management & Compliance

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  • 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

Technical PM (e.g. Labeling, Submissions)

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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

Information Management

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  • 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 & implementation
  • Business process-based application
  • Multi-functional approach
  • Data simplification
  • Challenge IT complexity
  • Connect information flows
  • Shared services for routine activities