Regulatory services

 

ESMAR company service in the field of Marketing Authorization (Registration certificate):

 - Translation of any dossier related documentation for further submission to Regulatory authorities;

 - Preparation of Dossier (Normative documentation) according to requirements of National Regulatory authorities;

 - Post-marketing support (amendments, changes, re-registration, etc.).

 


Medicines:

·     Analysis of the market of medical products;

· Marketing authorization (Registration) of medical products;

·     Re-registration and making changes;

· Inspection of manufacturing site (GMP confirmation).


Food and dietary supplement:

·  Analysis of the market of food and dietary supplements;

· Marketing authorization (Registration) of food and dietary supplements;

· Certification of food and dietary supplements.


Products of Medical Use - Medical devices and medical equipment:

·  Analysis of products of medical use devices and medical equipment;

· Marketing authorization (Registration)  of products of medical use and medical equipment;

·     Re-registration and making changes;

·     Sanitary and epidemiological conclusion;

·   Certification of products of medical use and medical equipment. 


Cosmetics, veterinary, disinfection:

·      Analysis of the market,

·      Marketing authorization (Registration); 

·      Certification

·      etc.

 

 ESMAR company service in the field of Regulatory Support of Clinical Trials:

 - Medical writing;

 - Translation of any study related documentation for the regulatory submission;

 - Preparation of the regulatory dossier according to requirements of national regulatory agencies;

 - Obtaining of a Local Insurance certificate for clinical trials;

 - Preparation, review and submission of documentation to the Central Regulatory Authority and Ethic Committees;

 - Obtaining of a study approval;

 - Obtaining of export and import licenses for study drug and materials;

 - Obtaining of export and import licenses for biological samples;

 - Submissions of Protocol Amendments, CIOMS reports, Annual Safety and Final Study Report to the Central

Regulatory Authority and Ethic Committees;

 - Ongoing communication with the Central Regulatory Authority and Ethic Committees

Communication with continuous and effective information flow ensures success.

ESMAR provides you with regulatory support at all stages of Marketing authorization and clinical trial projects.