Commercialization

JSS Medical Research India Ltd. (formerly Max Neeman International) offers fully integrated commercialization services to help clients maximize regional market access. We provide assistance with drugs & device registration and approval process in India along with market access strategies helping you make successful business decisions.

 

The team includes scientific researchers, regulators, and medical writers, as well as product development and management experts. These experts provide solutions for clients that are aligned to the product development and life cycle management processes. Also our regulatory experts have established relationships with the local Ministries of Health, and know how to complete the registration process.

 

As a part of regulatory affair services we prepare documentation and obtain marketing authorization as well as site & product registration for Drugs and medical devices. The services include:

  • Preparation of registration dossiers for marketing authorization applications
  • Preparation of registration dossiers Site & product registration
  • Updating/reformatting of the registration documentation
  • National applications with follow up until Marketing Authorization
  • Preparation of Periodic Safety Update Reports (PSURs)

Other services include:

  • Market access strategy
  • Publication strategy
  • Health outcomes analysis and economic modeling
  • Selection and management of distributors in major therapeutic areas