Regulatory Consulting

EMINENT personnel are experienced in the provision of quality clinical trial material management services for phase I to IV studies and have valuable knowledge of Good Manufacturing Practice (cGMP) Regulations as they apply to clinical study product development. EMINENT personnel are also well familiar with Investigational New Drug Application (IND), New Drug Application (NDA), and Drug Master Files (DMF) filing with the US Food and Drug Administration. Contract consulting services may be particularly useful to small, research based pharmaceutical and biotechnology companies that are entering into the clinical drug development for the first time, and to Contract Research Organizations (CRO) and Data Coordinating Centers (DCC) involved with clinical studies for clinical product development, patient specific packaging and labeling, distribution to clinical sites, and clinical site inventory monitoring.
  • Related Services Offered:
  • Regulatory Consulting Services
  • Total Quality Implementation
  • QA/QC/cGMP/ISO9001 Compliance Auditing
  • ND/NDA/ANDA/DMF Preparation
  • Clinical Protocol Review
  • Equipment Qualification and Process Validation
  • Shipping Configuration Validation
  • Validation and Mapping of Drug Storage Areas