[support in and to the USA ]

 

To be successful in the US market, non-US based Life Sciences companies optimally have an early US identity to work with FDA and to develop strategic partnerships with US companies.

Dr. Bruce Mackler (profile) at van Rooijen & Partners is also a principle of Life Sciences Management Group, Inc. (LSMG), which offers Non-US based Life Sciences companies a US identity through a shared office and experienced coordination staff in the Washington, DC area.

The LSMG principals, its staff and broad network of industry contacts have hands-on FDA and corporate partnering success experiences in pharmaceuticals, biologics, medical and in vitro diagnostic devices, cosmetics and non-regulated research/laboratory reagents and equipment. The LSMG principals have taken technologies from the laboratory through the FDA regulatory processes and into the marketplace. Through their broad experience and networks in the industry, LSMG can also support Non-US based companies with business development and strategic partnerships in the industry or with arrangements with solution providers in the US. They can provide Non-US based Life Sciences companies with quick cost efficient solutions based on hands-on experience to:

  • Organize contacts/meetings with FDA
  • Negotiate development programs with FDA
  • Serve as the US agent to FDA for investigation studies (IND’s/IDE’s) and marketing applications: 10(k)s/PMAs/NDAs/BLAs
  • Negotiate agreements based on current US industry standards with CROs, contract manufacturers, sales/distribution, clinical investigators and their institutions
  • Identify and negotiate with strategic partners
  • Organize and hire a staff for your US subsidiary

Non-US based Life Sciences Companies can rapidly add value to their financing activities through FDA confirmation of their product development strategies/timetables and earlier receptivity of strategic partnering candidates for product development and financing.

Through the collaboration with Life Sciences Management Group, Inc., we can serve your American needs even better.

For more information, contact Dr. Bruce Mackler in the USA at +1-240-314-0450; +1-858-459-0236; or by E-Mail, or contact a consultant near you.