Regulatory Affairs

We provide regulatory services to Active Pharmaceutical Ingredients, Drug Products & Food Products manufacturing facilities for followings:

ACTIVE PHARMACEUTICAL INGREDIENTS

• Compilation of DMF in CTD/eCTD format for US, Europe, Canada and ROW market
• Response on queries received from various regulatory authorities on submitted DMFs.

DRUG PRODUCTS

• Compilation of ANDAs in CTD/eCTD format for US, Europe, Canada and ROW market
• Response on queries received from various regulatory authorities on submitted ANDAS.