Regulatory Affairs
High-quality registration service is not an expense item, but an item of future income for our Partners.
We can help with the next types of registration:
– registration of strategically important medicinal products (national registration, valid only on the territory of the Republic of Belarus) according to the standard, simplified procedure, as well as for emergency use
— registration of medicinal products in accordance with the requirements of the Eurasian Economic Union — bringing them in line with the requirements of the Union
– re-registration (confirmation of registration) of medicinal products registered in the Republic of Belarus
— making variations to the registration dossier of medicinal products registered in the Republic of Belarus
— organizing an inspection to confirm compliance with the rules of Good Manufacturing Practice of the Eurasian Economic Union (GMP).
What do we offer:
Our services include not only the preparation of a registration dossier for submission and support of the registration process in the competence authorities of the Republic of Belarus, but also qualified consulting services at the stages of medicinal products development and pre-registration preparation, assistance in choosing a registration strategy, adapting the dossier in accordance with the regulatory requirements of the Republic Belarus.
What medicinal products do we work with:
Original medicinal products
biosimilars or bioanalogs (biotechnological, immunological products, including vaccines)
generic medicinal products of all dosage forms and pharmacotherapeutic groups
herbal medicinal products and vitamin-mineral complexes