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Cencora PharmaLex Logo
  • Cencora PharmaLex Logo
  • About Us
        • About UsWe are leading provider of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our priority.
        • SustainabilityWe are focusing our efforts on initiatives that revolve around education, empowerment and inclusivity and sustainability.
        • Management TeamOur management team is committed to create a friendly working environment, provide confidence to our customers and support a environmental-friendly company.
        • Our LocationsWe service our clients through our regional hubs that collaborate on projects at global, regional and local levels
        • Corporate Social ResponsibilityHaving the ability to invest in sustainable environmental and social wellbeing is an important part of our attitude to business as well as helping to reinforce our values.
        • TrainingEnhancing our industry by delivering high-quality specialist training courses.
  • Solutions
        • Industry Solutions

          • Strategic and Scientific Consultancy
          • Integrated Product Development
          • Innovations to Market
          • Optimal Patient Access
          • Business and Portfolio Mergers & Acquisitions
          • Strategic and Scientific Consultancy
          • Integrated Product Development
          • Innovations to Market
          • Optimal Patient Access
          • Business and Portfolio Mergers & Acquisitions

          Industry Sectors

          • Biotech
          • Pharmaceutical & Consumer Health
          • MedTech
          • Biotech
          • Pharmaceutical & Consumer Health
          • MedTech

          Departments

          Services

          Research and Development
          Statistics and Data Science
          Market Access
          Patient Safety (Pharmacovigilance)
          Regulatory Affairs and CMC
          Quality Management and Compliance
          Training
          Research and Development
          • Clinical Development Services
          • Clinical Trial Applications
          • Development Strategy
          • Toxicological Services and Risk Assessment
          Statistics and Data Science
          • Clinical Biostatistics
          • CMC Statistics
          • Data Strategy & Data Governance
          • Discovery Statistics
          • Omics Data Science
          Market Access
          • Health economics and outcomes research (HEOR)
          • Market Access Strategy
          • Pricing and Reimbursement
          Patient Safety (Pharmacovigilance)
          • Clinical Trials Adverse Event Processing
          • Gap Analysis and Consulting
          • ICSR Management
          • Literature Surveillance
          • Local Affiliate Pharmacovigilance Services
          • Monitoring and Signal Detection
          • Pharmacovigilance Audits
          • Qualified Person for Pharmacovigilance (QPPV)
          Regulatory Affairs and CMC
          • Agency Interactions
          • CMC Biologics
          • CMC Services
          • eCTD, System Operations and Data Management
          • Post-Approval Maintenance
          • Promotional Materials & Compliance
          • Regulatory Writing / Scientific and Technical Writing
          Quality Management and Compliance
          • Commissioning, Qualification and Validation
          • Computer System Validation (CSV)
          • GxP Audit
          • GxP Technical Consulting
          • Quality Systems and Compliance

          Enhancing our industry by delivering high-quality specialist training courses.

  • Solutions
    • Industry Solutions
      • Strategic and Scientific Consultancy
      • Integrated Product Development
      • Innovations to Market
      • Optimal Patient Access
      • Local Affiliate Services
      • Business and Portfolio Mergers & Acquisitions
    • Sectors
      • Biotech
      • Pharmaceutical & Consumer Health
      • MedTech
    • Departments
      • Research and Development
      • Statistics and Data Science
      • Market Access
      • Patient Safety (Pharmacovigilance)
      • Regulatory Affairs and CMC
      • Quality Management and Compliance
  • Insights
        • News & Events
          • Events
          • Company News
        • Thought Leadership
          • Webinars
          • White Papers
          • Case Studies
          • Infographics
          • Fact Flyers
          • Blog & Articles
          • Videos
          • Journal Articles
          • Podcasts
        • Journal Article

          Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment

          Journal Article
          • 22nd May 2025

          Why local language matters with medical information inquiries

          Blog & Article
          • 22nd May 2025

          Challenges and best practices for managing local pharmacovigilance activities

          Podcast
          • 9th May 2025
          • 12m
          Case Studies

          Regulatory case study: Outsourcing excellence drives growth for specialty pharmaceutical developer

          Case Study
  • Insights
    • News & Events
      • Events
      • Company News
    • Thought Leadership
      • Webinars
      • White Papers
      • Case Studies
      • Infographics
      • Fact Flyers
      • Blog & Articles
      • Videos
      • Journal Articles
      • Podcasts
  • Digital Innovation
  • Careers
  • Contact Us
  • Global Reach
Cencora PharmaLex Logo
  • Cencora PharmaLex Logo
  • About Us
        • About UsWe are leading provider of specialized services for the pharmaceutical, biotech and medical device industries, compliance is our priority.
        • SustainabilityWe are focusing our efforts on initiatives that revolve around education, empowerment and inclusivity and sustainability.
        • Management TeamOur management team is committed to create a friendly working environment, provide confidence to our customers and support a environmental-friendly company.
        • Our LocationsWe service our clients through our regional hubs that collaborate on projects at global, regional and local levels
        • Corporate Social ResponsibilityHaving the ability to invest in sustainable environmental and social wellbeing is an important part of our attitude to business as well as helping to reinforce our values.
        • TrainingEnhancing our industry by delivering high-quality specialist training courses.
  • Solutions
        • Industry Solutions

          • Strategic and Scientific Consultancy
          • Integrated Product Development
          • Innovations to Market
          • Optimal Patient Access
          • Business and Portfolio Mergers & Acquisitions
          • Strategic and Scientific Consultancy
          • Integrated Product Development
          • Innovations to Market
          • Optimal Patient Access
          • Business and Portfolio Mergers & Acquisitions

          Industry Sectors

          • Biotech
          • Pharmaceutical & Consumer Health
          • MedTech
          • Biotech
          • Pharmaceutical & Consumer Health
          • MedTech

          Departments

          Services

          Research and Development
          Statistics and Data Science
          Market Access
          Patient Safety (Pharmacovigilance)
          Regulatory Affairs and CMC
          Quality Management and Compliance
          Training
          Research and Development
          • Clinical Development Services
          • Clinical Trial Applications
          • Development Strategy
          • Toxicological Services and Risk Assessment
          Statistics and Data Science
          • Clinical Biostatistics
          • CMC Statistics
          • Data Strategy & Data Governance
          • Discovery Statistics
          • Omics Data Science
          Market Access
          • Health economics and outcomes research (HEOR)
          • Market Access Strategy
          • Pricing and Reimbursement
          Patient Safety (Pharmacovigilance)
          • Clinical Trials Adverse Event Processing
          • Gap Analysis and Consulting
          • ICSR Management
          • Literature Surveillance
          • Local Affiliate Pharmacovigilance Services
          • Monitoring and Signal Detection
          • Pharmacovigilance Audits
          • Qualified Person for Pharmacovigilance (QPPV)
          Regulatory Affairs and CMC
          • Agency Interactions
          • CMC Biologics
          • CMC Services
          • eCTD, System Operations and Data Management
          • Post-Approval Maintenance
          • Promotional Materials & Compliance
          • Regulatory Writing / Scientific and Technical Writing
          Quality Management and Compliance
          • Commissioning, Qualification and Validation
          • Computer System Validation (CSV)
          • GxP Audit
          • GxP Technical Consulting
          • Quality Systems and Compliance

          Enhancing our industry by delivering high-quality specialist training courses.

  • Solutions
    • Industry Solutions
      • Strategic and Scientific Consultancy
      • Integrated Product Development
      • Innovations to Market
      • Optimal Patient Access
      • Local Affiliate Services
      • Business and Portfolio Mergers & Acquisitions
    • Sectors
      • Biotech
      • Pharmaceutical & Consumer Health
      • MedTech
    • Departments
      • Research and Development
      • Statistics and Data Science
      • Market Access
      • Patient Safety (Pharmacovigilance)
      • Regulatory Affairs and CMC
      • Quality Management and Compliance
  • Insights
        • News & Events
          • Events
          • Company News
        • Thought Leadership
          • Webinars
          • White Papers
          • Case Studies
          • Infographics
          • Fact Flyers
          • Blog & Articles
          • Videos
          • Journal Articles
          • Podcasts
        • Journal Article

          Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment

          Journal Article
          • 22nd May 2025

          Why local language matters with medical information inquiries

          Blog & Article
          • 22nd May 2025

          Challenges and best practices for managing local pharmacovigilance activities

          Podcast
          • 9th May 2025
          • 12m
          Case Studies

          Regulatory case study: Outsourcing excellence drives growth for specialty pharmaceutical developer

          Case Study
  • Insights
    • News & Events
      • Events
      • Company News
    • Thought Leadership
      • Webinars
      • White Papers
      • Case Studies
      • Infographics
      • Fact Flyers
      • Blog & Articles
      • Videos
      • Journal Articles
      • Podcasts
  • Digital Innovation
  • Careers
  • Contact Us
  • Global Reach

Podcasts related to Regulatory Affairs and CMC

Early Access Programs
Podcast

Early access programs: What they are and how to plan for them

  • December 19, 2023
  • 15m
Medical Device Presubmission
Podcast

Managing the medical device pre-submission process with the FDA

  • January 30, 2023
  • 14m
The New Opportunity in Pharmaceutical Outsourcing Portfolio Maintenance
Podcast

The New Opportunity in Pharmaceutical Outsourcing: Portfolio Maintenance

  • July 6, 2022
  • 16m
Solving the Innovation Dilemma with Integrated Product Development
Podcast

Solving the Innovation Dilemma with Integrated Product Development

  • June 1, 2022
  • 12m

Company

  • About Us
  • Corporate Social Responsibility
  • Sustainability
  • Management Team
  • Sectors
  • About Us
  • Corporate Social Responsibility
  • Sustainability
  • Management Team
  • Sectors

Useful links

  • Contact Us
  • Imprint
  • Data Protection
  • Terms and Conditions
  • UK Modern Slavery Act Statement
  • Contact Us
  • Imprint
  • Data Protection
  • Terms and Conditions
  • UK Modern Slavery Act Statement

Solutions

  • Strategic and Scientific Consultancy
  • Integrated Product Development
  • Innovations to Market
  • Optimal Patient Access
  • Business and Portfolio Mergers & Acquisitions
  • Strategic and Scientific Consultancy
  • Integrated Product Development
  • Innovations to Market
  • Optimal Patient Access
  • Business and Portfolio Mergers & Acquisitions

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