Regulatory Affairs

IN2Pharma provides complete life cycle management in the Benelux territory. From initial strategy development up to market introduction. And once commercialized, we support or manage the regulatory files during their complete life cycle

An overview of the regulatory services that IN2Pharma can offer (non-exhaustive list):

Medicinal products

  • Initial strategy development
  • Preparation and submission of marketing authorization applications
  • Preparation, submission and follow up of variations, notifications and renewals
  • eCTD publishing and validation
  • Completion of national closings
  • Review and approval of artworks
  • Submission of ‘Notification de modification’ in Luxembourg
  • Update product databases (ex.: e-Compendium, Z-index)
  • Handle all regulatory product commercialisation steps
  • Creation of short SmPCs for advertising materials
  • Communication with manufacturers, health authorities and other stakeholders
  • Preparation, review and submission of RMA materials

Medical devices

  • Advice on the strategy for classification
  • Update product databases and web portal FAMHP
  • Review and approval of artworks
  • Handle all regulatory product commercialization steps

Food Supplements

  • Preparation and submission of notification dossiers in FoodSup
  • Review of advertising claims
  • Review and approval of artworks

Cosmetics and general goods

  • Review and approval of artworks
  • Review of advertising claims

Regulatory intelligence service

  • We help you to stay up to date with the current legislation and provide you with timely news updates
  • We share our knowledge and experience

Phone

+32 16 891 600

Location

Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium

Email

info@in2pharma.com

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