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Pharma & Biotech Consulting

Global Expertise,
Local Insight


Pharma & Biotech Consulting

Global Expertise,
Local Insight

Expertise in navigating regulatory requirements of global authorities (e.g., ICH, US FDA, EMA) and the Emirates Drug Establishment (EDE), including implementation of the recent Decree-Law effective January 2, 2025

Compliance with international Regulations & Guidelines

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Food and Drug Administration

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United Arab Emirates (UAE)

European-union-flag

European Union (EU)


Services offered by our experts:


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1. Strategic Partnerships

  • Government Collaboration & Public-Private Initiatives
  • Life Science Venture Capital (VC) Companies
  • Private Equity Firms Investing in Healthcare
  • Angel Investor Networks (Healthcare/Biotech)
  • Sovereign Wealth Funds / Government Investment Arms
  • From Concept to Collaboration
  • Accelerating Growth through Alliance
  • Dubai as Your Launchpad
quality

2. Quality and Compliance Services

  • GxP Compliance
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Commissioning, Qualification, and Validation (CQV)
  • Batch Release
  • Qualified Person (QP) Services
  • Supplier Audits & Oversight
  • Deviations, CAPAs, and Change Controls
  • Risk Assessments
  • Data Integrity
  • Interim Quality Management
  • Manufacturing & Operations
  • Packaging
  • Inspection
  • Transportation/Distribution
quality

2. Quality and Compliance Services

  • GxP Compliance
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Commissioning, Qualification, and Validation (CQV)
  • Batch Release
  • Qualified Person (QP) Services
  • Supplier Audits & Oversight 
  • Deviations, CAPAs, and Change Controls
  • Risk Assessments
  • Data Integrity
  • Interim Quality Management
  • Manufacturing & Operations
  • Packaging
  • Inspection
  • Transportation/Distribution
regulatory

3. Regulatory Affairs Services

  • Applications & Submissions
  • Marketing Authorisations
  • Response to Warning Letters
  • Audits & Remediation
  • Transportation/Distribution
  • Import & Export
  • Warehousing
  • Responsible Person (RP) Services
  • Agent Services
  • Pharmacovigilance
  • FDA Regulations
  • EMA Compliance
  • UAE Compliance
regulatory

3. Regulatory Affairs Services

  • Applications & Submissions
  • Marketing Authorisations
  • Response to Warning Letters
  • Audits & Remediation
  • Transportation/Distribution
  • Import & Export
  • Warehousing
  • Responsible Person (RP) Services
  • Agent Services
  • Pharmacovigilance
  • FDA Regulations
  • EMA Compliance
  • UAE Compliance
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4. Operational Services

  • Lifecycle Management
  • Operational Excellence (OpEx) & Continuous Improvement
  • Project Management
  • Technical Writing
  • Training
  • Staff Augmentation
  • Due Diligence
  • Board Advisory

2040 Consulting: Services Offered

I. Quality & Compliance Services

  • GxP Compliance
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Commissioning, Qualification, and Validation (CQV)
  • Batch Release
  • Qualified Person (QP) Services
  • Supplier Audits & Oversight
  • Deviations, CAPAs, and Change Controls
  • Risk Assessments
  • Data Integrity
  • Interim Quality Management

II. Regulatory Affairs Services

  • Applications & Submissions
  • Marketing Authorisations
  • Response to Warning Letters
  • Audits & Remediation
  • Import & Export
  • Warehousing
  • Pharmacovigilance
  • Manufacturing & Operations
  • Packaging
  • Inspection
  • Transportation/Distribution
  • Responsible Person (RP) Services
  • Agent Services
  • FDA Compliance
  • EMA Compliance
  • UAE Compliance

III. Operational Services & Strategic Partnerships

  • Lifecycle Management
  • Operational Excellence (OpEx) & Continuous Improvement
  • Project Management
  • Technical Writing
  • Training
  • Staff Augmentation
  • Due Diligence
  • Board Advisory
  • Law firms
  • Venture Capital Firms
Are your ready to grow your business?
 Please fill in your details below to be contacted by one of our Business Development Associates, or you can contact us directly at info@2040consulting.com