Our services cover comprehensive regulatory support for various sectors, including new chemical entity development, clinical trials, generics, medical devices, and mergers and acquisitions. We offer medical and clinical consulting once the product is developed.

Specifically, we provide:

• Maintenance of marketed products
• Registration of NDA/generics
• Life cycle management of products
• Oversight of CMC activities
• Post-marketing drug safety and pharmacovigilance
• Labelling updates and harmonization
• Product transfers and acquisitions
• Company mergers and acquisitions support
• Coordination of regulatory certificates
• Special project management