Regulatory affairs
Local regulatory affairs support in the Republic of Moldova for medicinal products, medical devices and food supplements.
Our services include
We support our partners throughout the product lifecycle, from authorisation and registration to post-authorisation activities and manufacturer price registration.
- Product authorisation and registration
- Preparation, review and submission of regulatory documentation
- Management of variations and renewals
- Product information updates
- Manufacturer price registration
- Communication and management of requests from the competent authorities
Authorisation and registration
We provide support for the authorisation and registration of medicinal products, medical devices and food supplements in the Republic of Moldova. We assist with the preparation, review and submission of the required documentation and manage communication with the competent authorities throughout the procedure.
Post-authorisation regulatory support
We provide regulatory support to maintain product compliance after authorisation or registration. Our services include variations and renewals, product information updates, and preparation of responses to requests from the competent authorities.
Manufacturer price registration
We provide support for the registration and maintenance of manufacturer prices for medicinal products in the Republic of Moldova. Our services include initial price registration, re-registration and price updates, preparation of the required documentation, and communication with the competent authority throughout the procedure.
Preparing to register a product in Moldova?
Let's assess the regulatory feasibility and the steps of the procedure together.