Regulatory Compliance

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.

  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.