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 :
- Overview of Product with respect to their claimed indications.
- Overview of Disease - as per indications.
- Product Mechanism of Action
- Purpose of Excipients/ Inert / Any Other Material
- Conclusion
- 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.
No comments:
Post a Comment