Contact us X


Regulatory Affairs

IN2Pharma provides the complete range of regulatory services from initial strategic and product development to preparation and submission of Marketing Authorisation Applications. Reduction of the time needed to reach the market is critical to a product’s success. The proper conduct of your Regulatory Affairs activities is therefore of considerable economic importance to the company.

Next to accelerating the ‘speed to market’, IN2Pharma can help your marketing department to formulate usable advertising claims and prepare Marketing Authorisation (MA) files. Contact us if you want to find out how IN2Pharma can provide Regulatory Affairs for your company.

Medicines

  • Compiling administrative dossiers, writing expert reports
  • Compiling pharmaceutical data
  • Managing relationships with manufacturer, international regulatory affairs and marketing department
  • Pre-clinical documentation
  • Clinical documentation studies
  • Pricing and reimbursement

Medical Material and Devices

  • Declaration in line with categories and European directives

Nutrients and Herbal Products

  • Composition of files
  • Efficient follow up of procedures according to national and European legislation
  • Registration of Herbal Medicinal Products conform the applicable FAMHP guidelines

Homeopathic products and cosmetics

  • Composition of Euro-standard files
  • Follow-up of procedures as required
  • Declaration of files and certification procedures for the anti-poison institute