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An Initiative towards providing better cost effective quality healthcare
Batavia Exports
International
Quality  
Regulatory Affairs

The Final objective is to ensure that good quality products are delivered to the end user as per customers needs. This is possible through a very firm commitment towards quality within every area of the organization. Every possible effort is done to ensure quality is maintained and there is a coninious supply of quality products.

We have a process for qualifications of our products and supporting manufactueres. This includes :

Basic Assesements

Plant Audits ( as and when required )

the process ensures :

- The manufacturing site follows and meets all the GMP requirements as required by the law of the importing country.

- Product finally delivered adhers to the standards and specifications required

Basis assesement inclused assurance of systems in place such as the manufacturing license, site master files, quality manufales, drug master files as the ase maybe. In case of site audits are required we outsource them to the experts and are audited by qualified auditors.

Product Registrations, site variations, validation, deficiency letters are a part of the product registration challenges faced today. The overall activities of the regulatory affairs divison is to obtain Marketing Authorization's for generic products in the developing world. A team is dedicated to the work of co-ordination, collectionof documents, compiling, preparing dossiers as requried yb each individual national registration authority and to maintain these Marketing Authorizations thereafter . Whether these are variation files for site transfer or API variation, all data and relevant documentation in the right form must be delivered to the customer and the Ministry of health covering lablels, leaflets, int eh language required.

Product Registrations

-Preparing and compiling all dossiers for varisou registraion needs
-Answering all deficiency letters.
- Updataion of dossiers as and when needed.
- Revalidation documentations for site transfers, additions-

The challenges are met by our teams along with the support of the manufacturer's and thier QA and QC Depts.

Partnership We are committed to build a long term relationship with all our business partners for mutual interest and benefits.

       
       

 

Committed to provide quality heathcare
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