Pharmaceutical Development

Regulatory Affairs and Auditing

  • Regulatory consulting related to chemical manufacturing for companies with pre-IND and post-IND projects. Includes, review of batch records, batch record preparation, CMC section or QOS-CE of CTA preparation.
  • Development of site-specific and project-specific SOPs (process, equipment, facility, administration)
  • Regulatory auditing
  • Review/analysis of SOPs, SOP improvement
  • Auditing of manufacturing facilities, chemical processes, batch records, contracts
  • Evaluation of CMO competence

Please see our Pharmaceutical Development brochure for more details or Contact Us.