Document Review/Preparation
Lachman Consultants has assisted hundreds of domestic and international clients in reviewing and preparing key documents for review by FDA. These documents include:
  • NDAs
  • INDs
  • ANDAs
  • NADAs
  • 510ks
  • PMAs
  • DMFs
Lachman also has extensive experience in:
  • Developing effective systems to comply with the requirements for adverse drug event (ADE) management and reporting
  • Reviewing product labeling, advertising, and promotional materials for regulatory compliance
  • Providing technical writing for protocols, reports, specifications, policies, and procedures

Back to FDA-Related Services