Documentation Preparation for Regulatory Review

After completing Nonclinical studies and auditing study reports, all GLP studies must be summarized for regulatory review documents.  PharmaLex Development Services can prepare these summary reports for inclusion into various regulatory submissions.

  • IND (CTD format), IMPD, CTA
  • Investigator Brochures (IB)
  • NDA or BLA (CTD format), DMF, EDMF