Pharmaceutical DossiersVivendo Pharma licences a number of pharmaceutical dossiers with added value to existing medical treatment.
Pharmaceutical dossiers are in eCTD format, ready to be registered in the EU, with stability data for all climatic zones for extra-EU registrations.
Pharmaceuticals can be registered in Europe according to Directive 2001/83/EC under the following articles:
- generic medicinal product application, 10(1)
- similar biologic product application, 10(4)
- well established use application, 10a
- fixed dose combination application, 10b
Vivendo’s range of products comprises high potential pharmaceuticals, with new optimised formulations, innovative delivery systems, and improved handling developed for patients with difficulties to swallow, oncology and paediatric populations.
Among the pharmaceuticals developments can be mentioned:
- Oral forms
- Film-coated tablets with immediate release (IR), sustained release (SR), delayed release
- Oral dissolving film (ODF)
- Chewable tablets
- Soft/ Hard capsules
- Liquid formulation: oral solutions and syrups
- I.m. injections
- Pre-filled syringes
Vivendo Pharma Switzerland is the trusted partner when it comes to expand and grow your business with success and confidence.