PharmDedict - Regulatory Affairs, Pharmacovigilance Services, Medicinal Products, Medical Devices, Cosmetics

Regulatory Affairs Consultants

Our Services – View all services »

Business Development

All our activities which are intended to assist our customers in expanding their business...
Regulatory Affairs, Pricing & Reimbursement

Marketing Authorization applications through MRP/DCP and national procedures...
Pharmacovigilance

In line with the latest implementation of the new pharmacovigilance rules...
Quality Assurance

QM and QA services...
Market Access Support

To our international clients interested in launching their products in Bulgaria...
Translations

Specialized translations of Product Information...
Design and Prepress

Our new line of services...

Bulgaria have joined the CESP system

Starting on 1 July 2019, the Bulgarian Drug Agency (BDA) announced they …
Bulgaria: managing alerts during verification and decommissioning of medicines

After February 9th 2019 the EU drug verification system (established by …
PharmDedict on Pharma Boardroom

Pharma Boardroom goes deep into key country markets, conducting hundreds …
Bulgaria: Medicinal Products Pricing Calculator

The prices of RX medicinal products are regulated by the National …
Romania: is there a requirement for local pharmacovigilance contact person?

With the amendments in the EU pharmacovigilance framework the Member States …
The obligation for local PhV contact person in Bulgaria

With the Bulgarian Drug Law amendments published on 21-Dec-2012 a new obligation …

BDA: further measures related to COVID-19

The Bulgarian Drug Agency (BDA) announced today (March 24, 2020) further …
Bulgaria: State of Emergency

Following the announcement late at night on March 12 that Bulgaria is about …
Romania: the drug agency announced restrictions related to COVID-19

The Romanian ANMDMR (Agentia Nationala a Medicamentului si a Dispozitivelor …