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+31 (0) 629075858Aristotelesstraat 16, 1064 LD, AmsterdamBulevardul Unirii 11, Bloc 2B, Sector 4, Bucharest
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RegPakBiopharma
RegPak BioPharma Consulting (“RegPak”) is a full-service consulting company based in Amsterdam and Romania. We offer a wide range of services in advisory, technical and administrative aspects to BioPharma, Medical Device and Nutraceutical Companies. We support our customers and their vendors, suppliers, and service providers to conduct their business both within regulatory compliance and with reduced risk. Accurately assessing and tailoring the needs of each project to individual client requirements. By working as a team, each stage of the project focuses on shortening the final timeline.
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  • About
  • Resources
  • Our Services
    • Menu iconAll Services
    • Menu iconDiscovery / Non-clinical
      • Strategy and Consulting
        • Non-clinical Development Concept
        • Study Design
        • Scientific Due Diligence
    • Menu iconClinical Development
      • Strategy and Consulting
        • Clinical Program Development
        • Statistical Services
        • Medical Device
      • Regulatory Affairs
        • Clinical Trial Applications (CTA)
        • CE Marking
        • Orphan Drug Designation
        • Pediatric Investigation Plan (PIP)
        • Scientific Advice
        • Early Access/Compassionate Use
      • Pharmacovigilance
        • Clinical Trial Safety Support
        • Pharmacovigilance Consulting
        • Medical Devices Vigilance
      • Quality
        • GxP Services
        • Interim / Contract QA
        • Quality Systems
        • Vendor Management and Oversight
        • ISO Compliance for medical devices
      • Clinical Trial Service
        • Site Selection & Clinical Trial Monitoring
        • Clinical Trial Documentation Authoring
        • Clinical Project Management
        • Independent Data Safety Monitoring Committee
    • Menu iconProduct Authorization / Market Approval
      • Strategy and Consulting
        • Market Access
        • Global Procedure Management
        • Medical Device
      • Pharmacovigilance
        • EU QPPV / National QPPV
        • Literature monitoring
        • Risk Management Support
        • Audit and CAPA Management
        • Medical devices Vigilance
      • Regulatory Affairs
        • CMC Services
        • Health Authority / Agency Interaction
        • Marketing Authorization and Labeling Activities
        • Scientific, Regulatory and Technical Writing
        • Environmental Risk Assessment
        • Leaflet readability testing
      • Quality
        • Commercialization Readiness
        • GxP Services
        • Interim / Contract QA
        • QP Services
      • Medical devices
        • Clinical Evaluation
        • Clinical and Safety Evaluation
        • ISO 13285 QMS
        • Notified Body Interactions
        • Authorized EU Representative
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        • Post Approval Commitments and Variations
      • Pharmacovigilance
        • Audit and CAPA Management
        • EU QPPV / National QPPV
        • ICSR Management
        • Literature Screening
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        • Safety Writing
        • Signal Management
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        • GxP Services/Audits
        • Interim / Contract QA
        • QMS Set-up
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        • Medical device compliance
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  • Customized
    • Product Expertise
      • Cosmeceutical
      • Small Molecules
      • Biologics
      • Cell, Gene and Tissue Therapies
      • Biosimilar/Follow-on Biologics
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Our specialists use technology-enabled solutions to guide you through the entire product lifecycle. We deliver extraordinary results — going outside the standard to deliver tailor-made solutions worldwide.

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Contact Info
  • NL Address:
    Aristotelesstraat 16, 1064 LD, Amsterdam
  • RO Address:
    Bulevardul Unirii 11, Bloc 2B, Sector 4, Bucharest
  • Business hours:
    In line with your global needs!
  • Phone number:
    Tele-Fax : +31 (0) 207729539
    Mobile: +31 (0) 629075858
  • Adverse event reporting
    safety@regpakbiopharma.com
  • General queries
    info@regpakbiopharma.com

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  • Clinical Development
  • Product Authorization / Market Approval
  • Post-approval / Maintenance
  • Customized Solutions
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  • Our Services
    • All Services
    • Discovery / Non-clinical
      • Strategy and Consulting
        • Non-clinical Development Concept
        • Study Design
        • Scientific Due Diligence
    • Clinical Development
      • Strategy and Consulting
        • Clinical Program Development
        • Statistical Services
        • Medical Device
      • Regulatory Affairs
        • Clinical Trial Applications (CTA)
        • CE Marking
        • Orphan Drug Designation
        • Pediatric Investigation Plan (PIP)
        • Scientific Advice
        • Early Access/Compassionate Use
      • Pharmacovigilance
        • Clinical Trial Safety Support
        • Pharmacovigilance Consulting
        • Medical Devices Vigilance
      • Quality
        • GxP Services
        • Interim / Contract QA
        • Quality Systems
        • Vendor Management and Oversight
        • ISO Compliance for medical devices
      • Clinical Trial Service
        • Site Selection & Clinical Trial Monitoring
        • Clinical Trial Documentation Authoring
        • Clinical Project Management
        • Independent Data Safety Monitoring Committee
    • Product Authorization / Market Approval
      • Strategy and Consulting
        • Market Access
        • Global Procedure Management
        • Medical Device
      • Pharmacovigilance
        • EU QPPV / National QPPV
        • Literature monitoring
        • Risk Management Support
        • Audit and CAPA Management
        • Medical devices Vigilance
      • Regulatory Affairs
        • CMC Services
        • Health Authority / Agency Interaction
        • Marketing Authorization and Labeling Activities
        • Scientific, Regulatory and Technical Writing
        • Environmental Risk Assessment
        • Leaflet readability testing
      • Quality
        • Commercialization Readiness
        • GxP Services
        • Interim / Contract QA
        • QP Services
      • Medical devices
        • Clinical Evaluation
        • Clinical and Safety Evaluation
        • ISO 13285 QMS
        • Notified Body Interactions
        • Authorized EU Representative
    • Post-approval / Maintenance
      • Strategy and Consulting
        • Market Access
        • Medical Device
      • Regulatory Affairs
        • CMC Services
        • Global Procedure Management
        • Health Authority / Agency Interaction
        • Marketing and Labeling Activities
        • Post Approval Commitments and Variations
      • Pharmacovigilance
        • Audit and CAPA Management
        • EU QPPV / National QPPV
        • ICSR Management
        • Literature Screening
        • Pharmacovigilance Set-up
        • Safety Writing
        • Signal Management
        • Medical devices Vigilance
      • Quality
        • GxP Services/Audits
        • Interim / Contract QA
        • QMS Set-up
        • Vendor Management and Oversight
        • Medical device compliance
      • Medical Affairs
        • Medical Information
        • Promotional Material Review
  • Customized
    • Product Expertise
      • Cosmeceutical
      • Small Molecules
      • Biologics
      • Cell, Gene and Tissue Therapies
      • Biosimilar/Follow-on Biologics
      • Medical Devices
      • Drug-Device Combinations
      • In Vitro Diagnostics
      • Companion Diagnostics
      • Foods and Nutraceuticals
      • Vaccines
    • Therapeutic Areas
      • Oncology
      • CNS
      • Infectious Diseases
      • Hematology
      • Autoimmune System
      • Cardiovascular Disease
      • Gastrointestinal
      • Metabolic Disorder
      • Ophthalmology
      • Dermatology
    • Industry Expertise
      • Biopharmaceuticals
      • BioTech Products
      • Biosimilars
      • Consumer Healthcare
      • Genetics
      • Herbal Medicines
      • Vaccines
      • Gene Therapy
      • Small Molecules
      • Medical Device
      • Health Supplements
    • Service Expertise
      • Clinical Trial Support
      • Regulatory Affairs
      • Pharmacovigilance
      • Medical Writing
      • EU Batch Release & Testing
      • Parallel Import
      • Distribution & Supply Chain Support
      • Quality Assurance
      • Early Access/Compassionate Use
      • Orphan Drug Development
    • Featured Expertise
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