U bent reeds aangemeld met het ingevoerde e-mailadres.
Uw e-mailadres is bekend bij ons, maar u staat op niet-actief in de ontvangstlijst. Wij hebben u een bevestigingsmail met een activeringslink gestuurd om uw account weer actief te maken en de nieuwsbrief in de toekomst te ontvangen.
U bent aangemeld voor de nieuwsbrief en ontvangt een bevestigingsmail op uw ingevoerde e-mailadres met daarin een activeringslink die u dient te volgen om uw aanmelding te bevestigen.
Het kan enkele minuten duren alvorens u deze e-mail ontvangt.
Linkedin
Slide background

Welcometo Interdos.

Slide background

InterdosWorld-wide consultancy services

Slide background

InterdosPharmaceutical products

Slide background

InterdosClinical trial authorisations

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.

onderdeel
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
  • CE marking
onderdeel
Clinical Study support
  • Study design
  • Preparation of study documents
  • Feasibility tests
  • Ethics Committee submissions
  • Development and updating of IMPDs for clinical trial application
  • Clinical trial authorisations
  • Statistics
  • Data management
  • Site monitoring
  • Project management
  • Medical writing
  • GCP audits
  • Availability of Clinical Trial Manager
onderdeel
Pharmacovigilance
  • 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
onderdeel
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
onderdeel
Auditing and training
  • GMP/GCLP
  • GDP
  • ISO 13485
  • Serialisation
  • Validation (processes, cleaning)
  • Pharmacovigilance
onderdeel
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
onderdeel
Services for Nutraceuticals/Food Supplements
  • Scientific and regulatory procedures
  • Supporting product/health claims
  • Product Development strategies
  • Development and compilation of product dossiers
  • Evaluation of safety
onderdeel
Services for Medical Devices
  • Regulatory consulting
  • Quality Systems consulting
  • ISO 13485 gap-analysis
  • ISO 13485 audits
  • Compilation of CE product dossiers
slide
Sign up for our newsletter
Register
logo
 
Burg. Lemmensstraat 352
P.O. Box 1124
6160 BC Geleen
The Netherlands

Phone: +31 (0)88 255 40 60
info@interdos.nl
You can report suspected adverse drug reactions / side effects of our medicines by sending an email to: pv@interdos.nl

In case of urgent safety issue please contact us: +31 (0)6 511 68 061
Linkedin Basic
© Copyright 2019 Interdos - All rights reserved. | Privacy Statement