Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA
In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections...
Qualified Person and Quality Expert Services
Our QPs and Quality Experts provide the following services, in accordance with the EU Good Manufacturing Practice (GMP) for medicinal products:
– Complaints handling;
– Product Quality Reviews (PQRs);
– Quality Management System implementation and update;
– EU Batch certification and product release;
– Technical / Quality Agreements;
– Host for regulatory and customer audits, GMP/GDP inspections;
– Self-Inspections;
– Mock recall test.
GMP and GDP Auditing Services
Our experts audit pharmaceutical manufacturing facilities and warehouses according to the EU Good Manufacturing and Good Distribution Practices. Our auditors create, maintain and track audit schedules and they plan and lead the audits. Audit reports are issued and the auditors track observations through CAPA and perform audit closure.
– Pre-inspection gap analysis audits;
– GMP/GDP audits (internal or at the suppliers).
In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections...
In the end of February 2019, the European Commission (EC) produced a letter concerning the withdrawal of the United Kingdom from the perspective of th...
After February 9th 2019 the EU drug verification system (established by the Falsified Medicines Directive (Directive 2011/62/EU) and further detailed ...
The Romanian Drug Agency (ANMDM) published on their website scientific decision No 4/24.10.2018 implementing the document of European Medicines Agency...