Regulatory Submissions

The experienced LBR’s Regulatory Affairs team can provide writing, preparation, and compilation of regulatory submissions and annual reports for INDs, NDAs, ANDA, BLAs, INADs and NADAs. We remain current with regulatory requirements and maintain open communication with our Sponsors so there are no surprises. LBR services cover all stages of product development including preclinical, clinical, and manufacturing.

The Team is experienced in the development and maintenance of:

  • Orphan Drug Application Preparation and Submission
  • eCTD Preparation & Conversion for all types of documents
  • Package Insert Development
  • Label Development & Review
  • Advertisement Copy Review
  • Regulatory Submissions (eCTD, IND, NDA, INAD, NADA, BLA, CTA)