The company will prepare all the documents as per the guideline of DMF and CEP and submit the file for approval for off patented product and for patented products we can develop the product and market patented product in the country where patent respect is less like Brazil, Mexico, Columbia, Venezuela, Turkey and some of the middle East & Russian countries but some of the company might need inspection.
Avant will follow Good Manufacturing Practices (cGMP) according to the International Conference of Harmonization (ICH) guidelines, and it will be inspected/audited not only by other companies, but also by local and international Health Authorities, such as DGDA (Bangladesh), FDA (USA), COFEPRIS (México), MINDZDRAV (Russia) and TGA (Australia).