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

Regulatory Affairs Consultants

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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...
Translations

Specialized translations of Product Information...
Market Access Support

To our international clients interested in launching their products in Bulgaria...
Design and Prepress

Our new line of services...

BDA: new requirements for the “proof of payment” document

Starting in February 2018, the Bulgarian Drug Agency (BDA) applies additional …
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 …