Regulatory
The pharma industry both in India and globally is on a constant growth curve and in this dynamic environment the government regulation and policies are always changing.
We have more than 400 dossiers in all formats including Standard, ACTD and CTD.
Unicorns has a distinguished regulatory department experienced in submitting dossiers in all different formats (as required by the respective country) and getting approvals from both regulated and semi regulated countries. The department in co-ordination Business Development team work towards the needs and wants of the business and their respective country regulations.
Our regulatory team comprises of more than 50 employees with diversified background from various different pharma companies. We have submitted more than 400 dossiers and 350 approvals.
The Bio-Equivalence studies & Clinical Trials are also arranged by the said department as and when required. Likewise, the permission for food products is also obtained from FSSAI after providing all the necessary documents pertaining to the products.
- Unicorns has centralized walk-in stability chambers for accessing stability of the products in different packing under different temperature and humidity conditions as per the requirement of different zones.
- Unicorns has appointed well Experienced Qualified and Competent Technical Personnel in various departments like Quality Assurance, Quality Control, Production, Personnel & Administration, Engineering & Warehouse and more.