Product Permission Documentation

Department of AYUSH and regulatory body is strengthening by new rules for product permission:

We (Ayurvedic Pharmacists) will prepare documentation for product permission with high standard.

Checklist:

Annexure-1 (List of Product)
Annexure-2 (Draft of Label)
Annexure-3 (Master Formula Card)
Annexure-4 (Quality Control Specification)
Annexure-5 (Proof of Effectiveness) 

Annexure-1 
List of Product : 
Were actual formulation details with Latin name of ingredients, form of ingredients with references.

Annexure-2 
Draft of Label :
Label content with pack details.

Annexure-3
Master Formula Card :
Formulation details, process SOP with production specifications.

Annexure-4 
Quality Control Specification :
Laboratory Testing Results will be provided by Company, on that basis setting up specification limits.

Annexure-5 
Proof of Effectiveness :
  1. Overview of Product with respect to their claimed indications. 
  2. Overview of Disease - as per indications. 
  3. Product Mechanism of Action
  4. Purpose of Excipients/ Inert / Any Other Material
  5. Conclusion
  6. Bibliography 
Our experienced experts will prepare these documents  only, then company has to take product permission from state regulatory by their own.

Time of preparation: 5 Days 

Mode of Submission : Email - Set of Document along with reference documents.

Note: 
If any documentation quarry raised by authority then we will resolve it with no extra cost but not responsible for any formulation quarries.

Along with complete product detail 100% Advance payment to be made for processing documents. 

Kindly mail us at sunconsultation@gmail.com for further queries. 
   


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