Service | DCGI submissions
Independent Representations in India: Serve as Authorized Indian Agent for Company in
Regulatory intelligence
Product Specific Requirements
Periodic Regulatory Updates
Precedents & Current thinking
Product specific Status Document
Regulatory submissions
Preclinical & Clinical Development Plans
Protocols, Investigator Brochures
Dossier Preparation (For all kind of submissions)
Prepare dossiers for various applications like Clinical trial approval (Form-45),
Manufacturing/import permission (Form-45 ),
Test license (Form-11),
Drug Registration certificate (Form- 41),
Import license (Form-10),
Neutral code, NOCs of different purpose,
Drug Sales license (Form – 20 B & 21 B),
CLAA approval, Manufacturing license (Form – 28, 28 A ),
Regulatory strategy
Scientific & Regulatory Assessment
Product Development Plan
Regulatory Strategy & Roadmaps
Risk Plans
About Us
Useful Links
NUVO provide Indian regulatory services, as follows
Cosmetics Registration certificate (Form- 43) etc.
Food Registration certificate (Form- A & B).
d: Review, Approvals, Maintenance
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