The regulatory team is continuously updated on the global regulatory framework for organizing data generation as per the required submission norms in the territory.

Enaltec Regulatory Team is working on submissions of Dossiers globally which will pave business for Enaltec in the coming years. This will include domestic as well as emerging market opportunities and registration of Finished products in highly regulated and competitive markets globally.

Our regulatory team is highly qualified to meet global regulatory standards and support for:

• Regulatory filing

• Regulatory Registration

• Abbreviated New Drug Registration (ANDA)

• Dossier Registration (EU and ROW markets)

• Drug Master File, CEP, ASMF Registration

• Variation Filing (Alternative Source, Site variation, etc.)

• Deficiency Addressal