iso certification services

Service Details:

DL – Drug License (20B, 21B – Wholesale Distribution License)

 

A License to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted license or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the case may be

 

A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted license or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.

                                            Procedure for  DL( Drug License )

Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form.

1.      User id Creation – Crate user id on FDA Portal for State  with required documents.

2.      Application to FDA – After verification of prepared documents, we will make an application to State FDA

3.      Inspection Plan - After application FDA officer will plan the inspection and will visit the location to verify the place, Competent Person and Legality of Company.

4.      License Grant : After successful completion of Inspection License Grant for 5 Years

Consultancy Charges – DL ( Drug License)

1.      Professional Fees  – 20000.00

2.      Out Of pocket Expenses – 10000- 35000 ( Depend upon location) will be as per actuals.

Govt Fees:

3.      Govt Application Fees  – 20B and 21 B – ( 1500 + 1500)= Total INR 3000.00

 

Timeline of Process

After application to DL ( Drug License)  – 30-45 Days.

Service Details:

DL – Drug License (20B, 21B – Wholesale Distribution License)

 A License to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted license or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 –B, as the case may be

 A license to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted license or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be.

Procedure for  DL( Drug License )

Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form.

1.      User id Creation – Crate user id on FDA Portal for State  with required documents.

2.      Application to FDA – After verification of prepared documents, we will make an application to State FDA

3.      Inspection Plan - After application FDA officer will plan the inspection and will visit the location to verify the place, Competent Person and Legality of Company.

4.      License Grant : After successful completion of Inspection License Grant for 5 Years

Consultancy Charges – DL ( Drug License)

1.      Professional Fees  – 20000.00

2.      Out Of pocket Expenses – 10000- 35000 ( Depend upon location) will be as per actuals.

Govt Fees:

3.      Govt Application Fees  – 20B and 21 B – ( 1500 + 1500)= Total INR 3000.00

 

Timeline of Process

After application to DL ( Drug License)  – 30-45 Days.

Service Details:

Product Certification (ISI Mark)

The Product Certification Schemes of BIS aims at providing Third Party assurance of quality, safety and reliability of products to the customer. Presence of BIS certification mark, known as Standard Mark, on a product is an assurance of conformity to the specifications. The manufacturer is permitted to self-certify the licenced products after ascertaining its conformity to the Standard. Through its surveillance operations, the Bureau maintains a close vigil on the quality of certified goods. The conformity is ensured by regular surveillance of the licensee’s performance by surprise inspections and testing of samples, drawn both from the market/factory.

ISI mark. ISI mark is a mark for industrial products in India. The mark certifies that a product conforms to the Indian Standard(IS), mentioned as CM/L-xxxxxxx on top of the mark, developed by the Bureau of Indian Standards (BIS), the national standards body of India.The ISI mark is granted to a product after it has been thoroughly tested by an approved laboratory of BIS. In this process applicant is required to submit the filled application form along with documents required and demanded fee to the Branch Office under whose dominion the manufacturing unit is located. 

Shamkris team (use as method Known as IRALG)
I - Indentification of Product Standard applicable
R- Readiness of documents required by standard & Dept.
A- Application to respective Department 
L- Liaosn with Department for Inspection
G -Grant of license  

Procedure for Certification (ISI Mark License)

1.      Documentation – Preparation of documentation as per prerequisite document checklist and applicable Indian Standard.

2.      Application – After verification of prepared documents, we will make an application to BIS. And BIS will check and revert if any additional documents required.

3.      Inspection – BIS will plan Preliminary Inspection at manufacturer premises. Inspecting Officer will verify plant and machinery, Testing equipements, Quality control personal testing knowledge and other requirements. Also selected random sample for verification and testing in BIS approved lab during Visit.

4.      Testing – After inspection sample will submitted to BIS Lab for Testing.

5.      Grant of License – If product sample passed in BIS approved lab, license will granted to manufacturer.

Timeline of Process

For Indian Manufacturer - After Application it will take 1-2 months.

 

For Foreign Manufacturer – After Application it will take 4 – 5 months.

Maximizing the life-cycle return on investment for capital assets, without compromising on safety or risking the environment is critical in today’s complex multi-stakeholder situations. How can you demonstrate you have embedded asset management best practice and differentiate your organization from others?

What is ISO 55001?

The ISO 55000 series of standards has brought the most successful publicly available specification: PAS 55 to organizations globally, bringing consistent terminology, guidance and a robust management systems framework built upon 24 best practice aspects to the discipline of asset management. ISO 55001 Asset Management System (AMS) implementation drives cost efficiency, value creation and risk management across the life-cycle of assets, from their design and fabrication or construction through commissioning, operations, maintenance, modification and renewal to their eventual disposal or decommissioning.

 

WHAT ARE THE BENEFITS OF ISO 55001?

 

• Manage an asset throughout its lifetime to improve performance• Identify risks and balance them against cost efficiency in all decisions• Improve return on investment or optimize growth across the asset life-cycle• Create a common language between operational and financial departments• Foster the sharing of asset management best practices between departments and sites• Reduction of cost• Priority setting for asset management maintenance

 

 

 

Management system certification provides a proven framework for the establishment, maintenance and continuous improvement of internal quality processes and other processes. It represents a global reference for market access and a ticket to trade. it includes all types of ISO certification