Regulatory Affairs

Advice on the authorization of medicines by means of the national procedure, MRP, DCP

Advice on changes in marketing authorization, line extension, notifications - in line with Directive 2001/83/EC, Article 61 (3), renewal, transfer of marketing authorizations

Advice on changing the legal status (RX-OTC) of the medicinal product for human use

Advice on GMP, GPhVP, GDP

Advice on the approval and implementation of campaigns/advertising materials

Advice on the registration in the national database of Medical Devices

Notice for placing food supplements on the market with the MH/NRDIFB

Advice on obtaining the authorization to use last resort treatment

Advice on obtaining authorization for special needs

Legislation monitoring

Specialized legal assistance

GxP Advice

Audit of service providers

Audit of manufacturers of active substances, packaging materials and excipients

GxP training/courses

Advice on preparing the BPD authorisation/certification file for the wholesale distributors of medicines for human use

Advice for administrative changes (Changes Annexes Wholesale Distribution Authorisation)

Audit to assess the degree of compliance prior to a NAMMDR inspection

Advice on optimizing the inspection process

Advice on providing the optimal response to the plan of measures submitted by NAMMDR following the deficiencies found

Advice on improving the quality management system

Advice on the interpretation of GMP/GDP regulations

Advice on obtaining a medical device distributor license

Advice on preparing the authorization file, changing the holder - legal entity, changing the chief pharmacist, for the community pharmacy for human use

Legislation monitoring

Specialized legal assistance

Pharmacovigilance

Pharmacovigilance audit support

KPI Report Preparation

SUSAR Reporting

PSURs (safety update reports)

QPPV Services

Risk Management Plan

Monitoring for social media and medical forums for SE reporting, scientific events, local medical literature

Standard Operating Procedures (SOPs)

Legislation monitoring

Specialized legal assistance

Communication and Marketing

Representation of the beneficiary before the competent authorities (MH, NHIH, NAMMDR, NRDIFB, PHNI, etc.)

Representation of the beneficiary in communicating with healthcare professionals, with the purpose of organizing medical events

Representation of the beneficiary in relating with patient associations

Organizing events for launching pharmaceutical products on the market

Organizing scientific and commercial events

Advertising and PR services

Drawing up educational materials needed for media campaigns

Media monitoring

Support activities for marketing purposes (specialized medical translations, warning labels, packaging, advertising materials for patients)

Legislation monitoring

Specialized legal assistance