Elfin having gained a foothold in the domestic market since its inception took steps towards a very natural progression into ventures in the overseas market in October, 2012.In addition to consolidating its business in developing countries, Elfin is working towards creating a global footprint by entering mature markets like North America and Europe.The endeavour was to tap on the ever increasing demand for the products on a global platform even as this sector kept growing exponentially.
By leveraging its competencies in R&D, manufacturing and business development, Elfin seeks to take advantage of attractive opportunities in the generic segment in developed markets.
Thus began Elfin's journey into the geographical sphere. Initially it entered itself in Phillipines, Myanmar,Georgia and looked to grow from thereon. We have our eyes firmly set on tapping the highly dynamic Asian and Latin America markets.
We are ready to surge ahead in the ever growing and ever challenging global market.
The company systems act as a guiding tool for the product development, manufacturing, distribution and these functions are carried out in accordance with the regulatory requirements of the specific country. The regulatory department at Elfin acts as an interface with the R&D, Manufacturing & Marketing and keeps itself abreast of the latest regulatory guidelines of the health authorities such as US-FDA, EDQM, TGA etc.
Our regulatory process also covers:
Submission of product registration applications in the form of CTD-Dossiers, marketing applications, ANDA, NDA etc.
Response to queries or deficiencies from regulatory bodies / customers.
Inspections and inspection reports.
Post approval / marketing surveillance by regulatory bodies.
Submission of annual updates to regulatory bodies.
