HPM has extensive experience advising clients on the regulation of bulk ingredients, including controlled substance bulk ingredients, from assistance with inspections and responding to FDA Form 483s and Warning Letters issued to these manufacturers, to issues regarding materials management, production and process controls, repackaging, storage and distribution, validation, change controls, laboratory controls, packaging/labeling and the rejection and re-use of materials. HPM also has extensive experience in advising bulk ingredient suppliers that provide such ingredients to pharmaceutical compounders.

  • Excipient Manufacturers
  • Active Pharmaceutical Ingredient Manufacturers
  • APIs Manufactured by Cell Culture/Fermentation
  • APIs for Use in Clinical Trials
  • Contract Manufacturers