MEDATEQ LABS can assist Pharmaceuticals / Food / Cosmetic / Medical device companies to register and carry out liasoning work with DCGI – Drug General Controller of India.
DCGI is responsible for Regulation of Drug & Cosmetics in India.
MEDATEQ LABS provides the following service with regards to DCGI
Import Registration of Drugs / API in India / Form 43 registration with DCGI India.
Site Registration with DCGI India
Cosmetic Registration for import in India. – Form 44
New product License for manufacturing in India
FSSAI registration i.e. Food & Ingredients registration in India
BE Studies NOC
WC registration In India
Medical Device Registration with DCGI
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 ),
Cosmetics Registration certificate (Form- 43) etc.
Food Registration certificate (Form- A & B).
If you are Pharmaceutical, Cosmetic, Food, Medical device company looking to export your products in India , MEDATEQ LABS can help you identify regulatory requirements regarding your :
Product
Label
Claim
Banned Ingredients
Regulatory Status of Your Product – For ex – OTC Product /Prescription Only
Import Agents
Market Research for Similar Products with matching label claim etc