Regulatory Affairs
• Medicinal products for human use • Medicinal products for veterinary use • Medical devices • Cosmetics • Food supplements
Regulatory Affairs
Life cycle management: Preparing, submitting, and following up until approval of an MA, variations, renewals, terminations and any regulatory procedures required for the maintenance of an MA
Preparing and writing documents/technical reports for the dossier (medicinal products, medical devices, cosmetics, food supplements)
Writing clinical and non-clinical expert reports
Labeling: preparing, analyzing and controlling artworks and mock-ups for medicinal products, medical devices, cosmetics, and food supplements
Complete readability testing and bridging
Providing support for the regulatory strategy and scientific advice
Licensing for the distribution of medicinal products, medical devices, and cosmetics
Registering and supporting the payment of fees to the competent authority
Technical advice and communication with the competent authorities
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