Get in touch with G&L Scientific today!

Warren, NJ   |   Boston, MA   |   San Diego, CA   |   Los Angeles, CA  |  Boca Raton, FL
E: hello@gandlscientific.com
London   |   Belfast   |   Marlow
E: hello@gandlscientific.com

Regulatory Submission Writing

Our services include:

  • Clinical and Non-clinical writing
  • Briefing Books/Meeting Requests
  • Assessment Aids/RTOR packages
  • IRs, Response to Questions
  • IND, CTA content
  • NDA, BLA, MAA, PMA content
  • General Investigational Plan (1.13.9)
  • Non-clinical Overview (2.4)
  • Non-clinical Summaries (2.6)
  • Clinical Overview (2.5)
  • Clinical Summaries (2.7)
  • Integrated Summary of Safety (ISS)
  • Integrated Summary of Efficacy (ISE)
  • Orphan Designation
  • Fast Track/ Breakthrough, Accelerated Approval
  • iPSP/ PIP
  • Literature Review
  • Style Guide Creation

Contact us today

For more information on Regulatory Submission Writing, please fill in the form and we will respond to you as soon as possible.

Service Form

Keep up to date with the latest industry news and trends
Newsletter Signup
Validation

Worldwide Locations

|
G&L Scientific G&L Scientific G&L Scientific G&L Scientific G&L Scientific