Our Services
We work closely with your team and help develop solutions tailored to meet your requirements.
Licensing
Indian Regulations & Guidelines: Drugs
Pharma Regulatory Organizations & Acts - India
These are the bodies that perform various functions for Drugs & 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.OTHER WORKS
• 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
Dossiers
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.