We assist in retrieving various legal documents are
Indian Regulations & Guidelines: Drugs
Pharma Regulatory Organizations & Acts - India These are the bodies that perform various functions for drug & cosmetic regulations in India. We offer consultation and execution of all formalities in order to clear compliance and regulations. This is to create market authorization for manufacturers, importers & distributors in India.
Central Drugs Standard Control Organization - (CDSCO)
NPPA: For drug pricing & other orders. National Pharmaceutical Pricing Authority (NPPA) is under the Government of India.
The Drugs & Cosmetics Act, 1940.
The Pharmacy Act,1948: In order to regulate the profession of Pharmacy in India.
Objectionable Advertisement Act, 1954. This act discourages advertisement that state miraculous or magical effects of drugs and cosmetics.
Dossier is a document file which has administrative quality, clinical & non clinical. which is need to submit in Food & Drug Administration of the concerned Ministry of Health, of Regulatory Authority.
TPRAC Provides Dossier service in Preparation, Review and rectify the quires as per the respective Regulatory Authority Guidelines. We are following as per ICH M4 (Common Technical Document). We are offering Asian, Africans & CIS Market.
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