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Best Business Practices (Or Lack Thereof) and Legal Challenges with Indian CRAMS/CMOs Outsourcing


Ram Balani (CEO and Founder, FDASmart Inc.)

Date: Wednesday, April 25

Time: 11:45am - 12:30pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Manufacturing

Vault Recording: TBD

How Not to Remain Sleepless with India Pharma Services Outsourcing?

This session will review best business practices and legal challenges with Indian CRAMS/CMOs Outsourcing and provide the following key takeaways:

  • Overview of Indian pharmaceutical CRAMS services and key vendors
  • East vs West – Two can Tango but “watch your feet” - Business practices and cultural differences, time zones issues and more
  • Latest Indian Legal Landscape Overview
    • Companies Act 2013 – How Indian companies must perform with commercial engagements including corporate regulatory compliance
    • Best practices for resolving US-India legal disputes
    • International arbitration
    • Long arm statutes
    • US jurisdiction on Indian companies-alter ego vs agency doctrines simply explained in English including an example of litigation with an Indian CRAMS in New Jersey
    • Case study featuring New Jersey litigation public court records
  • Overview of SEBi (India’s SEC) and PoEM for tax residency by CBDT (India’s IRS) roles and regulatory compliance
  • Contract Act 1872 – Explore both similarities and differences between US and India with US/India Contract laws highlights
  • Hindu Undivided Family (HUF) - Know who you are dealing with in India when it comes to signing commercial contracts, agency agreements etc.
  • How to handle disputes with India-forum jurisdictions, applicable laws governing contract matters, other must-have explicit contract clauses for US-Western clients
  • Review of the National Company Law Tribunal (NCLT) and the tribunal’s powers for grievances