Regulatory and Compliance

FTUP provides a one-stop solution for regulatory consulting.Our services include gap analysis of regulatory submissions such as ANDA and EU CTD, eCTD conversion, assistance for COS certification, drug master file submission, maintaining regulatory life cycle for the products such as amendments, annual reports and supplements and advises on deficiency responses.

FTUP regulatory covers product registration, pre-approval and post-approval activities. The below-listed activities are a reflection of general work undertaken but are not limited by it.

  • Strategic Regulatory filing with the US FDA – NDA, ANDA, Para IV, and 505 (b) (2) applications.
  • Submission preparation to other worldwide agencies like European countries, Australia, and Canada.
  • Development of regulatory strategy for the product’s life cycle
  • Facilitate regulatory interaction with regulatory agencies (Controlled Correspondences)
  • Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical, and toxicology matters
  • Advise and Respond to regulatory agency questions/responses.
  • Provide expert regulatory CMC compliance advice throughout the development
  • Act as US Representative for US submissions
  • eCTD compilation and Filing with the US FDA and other regulatory agencies
  • Regulatory Intelligence
  • Preparation and submission of deficiency response to FDA inquiry, Adverse Event Report, and Annual report
  • Gap analysis of regulatory documents
  • Clinical study and Equivalence advisee

Compliance Services

  • Pre-Approval Inspection Services
  • FDA Deficiency Response Preparation
  • Post-audit compliance response and implementation of corrective and preventive actions
  • SOP preparation and review Services
  • Quality Management – Effective Quality Systems implementation and Organizational Regulatory Compliance
  • Laboratory Auditing
  • Vendor Audit and Qualification
  • Training and development
  • Review of documents for regulatory submission

FTUP may provide regulatory advice to the customers as per their needs.