Metina PharmConsulting Private Limited offer service "EU GMP"

Metina manages EU GMP projects end to end, from pre-audit inspection, EU GMP slot arrangement and obtaining the T&C letter from the authority, through preparing the plant for inspection with attention to Hungary-specific regulatory expectations, supporting the inspection itself, obtaining the inspection observation report, submitting CAPAs, securing the EU GMP certificate, and publishing it on the EudraGMP website. Sites are approved or under approval for dosage forms including oral solids (tablets, capsules, soft gelatin capsules), oral liquids, dry syrups, topicals (ointment, cream, gel), liquid and lyophilized injectables, dry powder injectables for cephalosporins and beta-lactams, hormonal injections, lozenges, metered-dose inhalers, sterile eye/ear drops, prefilled syringes, oncology oral solids and injectables, and biosimilar drugs.