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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

Our team of experts posseses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory support, clinical studies, pharmacovigilance services and quality assurance activities.

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
  • Herbal medicinal products
  • 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 for EU batch release / batch certification
Auditing and training
  • GDP
  • ISO 13485
  • Serialisation
  • Validation (processes, cleaning)
  • Pharmacovigilance
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
  • Regulatory consulting
  • Quality Systems consulting
  • ISO 13485 gap-analysis
  • ISO 13485 audits
  • Compilation of CE product dossiers
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Burg. Lemmensstraat 352
6163 JT Geleen
The Netherlands

Phone: +31 (0)88 255 40 60
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