Our facility is an Export Oriented Unit (EOU) inspected and approved by various regulatory agencies including USFDA and UKMHRA.
Has several approved Abbreviated New Drug Applications (ANDA’s), Marketing Authorization (MA’s) Dossiers.
Technical experts perform analytical and in-process quality control and assurance, and systems and processes review.
Separate team plans and executes technical trainings as part of company’s continuous improvement plan.
Regulatory affairs team compiles and monitors all regulations, manages filing requirements across the globe, and submit queries and annual reports. Dedicated team follows Pharmacovigilance from site.
