05 / SERVICES
Market access
We define the pathway, build the evidence and manage each interaction required to bring the product to market.
Assess this pathway- 01
Regulatory feasibility assessment and strategy definition for new products.
- 02
Definition of the regulatory pathway and applicable requirements.
- 03
Regulatory consultations and product classification.
- 04
Strategy and management of responses to health authority requests.
- 05
Comprehensive dossier preparation, review and management for new registrations.
- 06
Changes to registration conditions (MCR).
- 07
Registration renewals.
- 08
Equivalences and abbreviated regulatory pathways.
- 09
Certificates of Free Sale.
- 10
Advertising notices and permits.
- 11
Import permits.
- 06
- 12
Management of tests and studies required for health registration.



