GMP BIOPHARMA CONSULT SPRL. was founded in 2013 to offer services according to international "CGMPs" used in pharmaceuticals and biologicals, 21CFR Regulations, Eudralex requirements (Directive 2003/94//EC ) and relevant guidances.
The company would like to share with customers international GMP experience acquired by the Director during last 30 years in 2 of the top 5 worldwide pharmaceutical and biological leaders.
Consultancy services are audits, FDA and EMA inspection preparations, trainings, QA. System implementations and contractor management models in APIs, solid and liquid dosage forms,and mainly in aseptic, sterile and biological processes.
We enjoy creating suitable solutions for small companies , but also support large Groups. They are pleased with their positive feedback.
Let's build and improve GMP compliance together.