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 (e.g.: 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
Interested? Get in touch!

Medical devices

  • Advice on the strategy for classification
  • Update product databases (e.g. web portal FAMHP, Notis)
  • Review and approval of artworks
  • Handle all regulatory product commercialization steps
Interested? Get in touch!

Food Supplements

  • Preparation and submission of notification dossiers in FoodSup
  • Review of advertising claims
  • Review and approval of artworks
Interested? Get in touch!

Cosmetics and general goods

  • Review and approval of artworks
  • Review of advertising claims
Interested? Get in touch!

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
Interested? Get in touch!

Phone

+32 16 891 600

Location

Hof Ter Loonst
Terloonststraat 22
1910 Kampenhout
Belgium

Email

info@in2pharma.com

Social Media

Junior Consultant vacancy

Are you keen to discover the pharmaceutical industry and to get introduced to Quality Assurance, Pharmacovigilance, Regulatory Affairs and/or Promotion & Publicity for pharma and healthcare products? As Junior Consultant at IN2Pharma, you will be trained in several of these domains and depending on your skills and interest, we will find out together where your passion lies. Do you hold a Master degree in pharmaceutical or other sciences and are you eager to learn? Apply by sending your CV and motivation to jobs@in2Pharma.com

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Medical Affair Vacancy

We are looking to expand our team with a Medical Affairs colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people
and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.

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QA Consultant

We are looking to expand our team with a Quality Assurance colleague who has the ambition and potential to grow in our organization. All projects within IN2Pharma are worked on in small teams of 2-5 people and for some projects, you also work on site at the clients’ offices for (max.) 1 or 2 days per week.

Download Vacancy