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 Ind-Swift 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.
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.