- Dossier Preparation specific to country’s regulatory requirements.
- Plant Audit (GMP Audit) – Inspections as per WHO-GMP guideline
- Regulatory Training for the employees – Skill Training
- Handling of warning letter, 483 observations management
- Regulatory strategic planning specific to business regions.
We manages regulatory services for following regions –
EU, US, GCC, Latam, African and ASEAN countries.