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Welcometo Interdos.

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InterdosWorld-wide consultancy services

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InterdosPharmaceutical products

Interdos provides the following services

Interdos is a service provider for pharmaceutical and medical-related companies. Our team of experts possesses in-depth knowledge and extensive experience in a comprehensive range of professional services, including regulatory support (for pharmaceutical and medical devices, including PRRC), pharmacovigilance services (including QPPV), quality assurance activities (including QP and RP), and laboratory services (EU QC release).

Regulatory Affairs
  • Advice on regulatory strategy and EU legislation
  • Regulatory due diligence
  • Dossier preparation, submission (national, MRP, DCP), maintenance and variations
  • Development and updating of eCTD registration dossiers
  • Compilation of Modules 2.3, 2.4 and 2.5
  • Compilation of labels, leaflets, SmPC and mock-ups
  • Readability testing of Patient Information Leaflets
  • Assessment of registration dossiers
  • Applications for scientific advice
  • Change of Legal status
  • Biological medicinal products and biosimilars
  • Medical devices in compliance with the Medical Device Regulation
  • CE marking
  • Screening of world wide literature
  • Compiling of Risk Management Plans (Module 1.8.2)
  • Compiling of periodic safety update reports
  • Submission of cases
  • Signal detection
  • Handling of reports
  • Pharmacovigilance  training
  • 24/7 availability, offering Qualified Person for Pharmacovigilance
  • Compilation of Pharmacovigilance System Mater File (PSMF)
  • Compilation of the summary of PV Master File (Module 1.8.1)
  • Audits of pharmacovigilance systems
  • Support of CAPA as a result of audits and inspections
Quality Services
  • Development and update of QA systems
  • Preparation of SOPs
  • GMP/GDP audits, monitoring and training
  • GMP Implementation services
  • Technical and logistical support
  • Applications for Manufacturing and Wholesalers Licenses
  • Offering Qualified Person (QP) / Responsible Person (RP) for EU batch release / batch certification
Laboratory Services
  • GMP batch testing and batch release services for pharmaceutical products, including release by QP or RP.
  • Release testing and drug stability testing services for a wide range of pharmaceutical products, such as tablets, solutions, and ointments.
  • Well-equipped facilities
  • Experienced team of lab scientists
  • Strategic partnerships to ensure accurate and comprehensive testing solutions.
  • Climate-controlled stability chambers meeting industry standards.
Auditing and training
  • GMP
  • GDP
  • ISO 13485
  • Serialisation
  • Pharmacovigilance
  • Documentation and self-certification based upon MDR
Contract Marketing Authorisation Holder
  • Opportunity for companies to use Interdos as applicant and Marketing Authorisation Holder for human medicinal products
  • Performing all communication with competent regulatory authorities
Services for Medical Devices
  • Delivering a PRRC to your company
  • Regulatory consulting
  • Quality Systems consulting
  • ISO 13485 gap-analysis
  • ISO 13485 audits
  • Compilation of CE product dossiers
Burg. Lemmensstraat 352
6163 JT Geleen
The Netherlands

Phone: +31 (0)88 255 40 60
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