Our Services

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.

Pharma Licensing & Others

• Manufacturing Licence
 Drug Manufacturing Licence
 Ayurvedic Manufacturing Licence
 Herbal Manufacturing Licence
 Cosmetic Manufacturing Licence
 Medical device Manufacturing Licence

Pharma Regulatory Organizations & Acts - India

• Drug Licence Approvals
 New Drug Approval
 FDA approvals
 Investigational new drug approvals
 Subsequent new drug approvals

FSSAI Approvals

 Neutraceuticals
 Food supplements
 Probiotic
 Prebiotic
 Herbal
 Ayurvedic functional food
 Novel foods
 Health Drinks & Supplements
 Protein Supplements

The Narcotic Drugs and Psychotropic Substances Act, 1985

For prevention of distributions, manufacture and sale of narcotic drugs in India.

• Issue of FSC ( Free Sale Certificates)
• COPP (Certificate of Pharmaceutical Products)
• Non Conviction Certificate
• Validity Certificate of Licence
• Performance Certificate

Other Licences & Approvals

• Cosmetics Licence
• Medical Devices Licence
• Biological product Licence
• Narcotic & psychotropic Licence
• Import & export Licence
• Explosive Licence
• Pollution Licence
• Whole Sale Licence
• Repacking Licence
• Retail Licence
• Loan Licence


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.

Satisfied Clients

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