Toxicology


PROFESSIONAL NONCLINICAL SERVICES
(Pharmacology, Pharmacokinetics, Toxicology)

  • Preparation for and subject matter expert representation during due diligence activities
  • Nonclinical program design, protocol development and execution
  • Bid solicitation and Contract Research Organization (CRO) selection for GLP and non-GLP studies/programs
  • Critical evaluation of CRO competencies and facilities
  • Monitoring of outsourced nonclinical studies to ensure compliance to study protocol, GLP regulations, and CRO Standard Operating Procedures (SOPs)
  • Review and interpretation of nonclinical data
  • Preparation of nonclinical assessments
  • Review and integration of the scientific literature
  • Strategic integrated nonclinical development plans
  • Clinical starting dose selection based on nonclinical safety data

    • REGULATORY DOCUMENT PREPARATION AND REVIEW

  • Nonclinical report and summary preparations
  • Preparation of nonclinical components of key regulatory submissions (e.g., Pre-IND information packages, INDs, IMPDs, NDAs)
  • Preparation of submission-ready CTD-format Tabulated and Written Summaries
  • Preparation of nonclinical components of key regulatory documents including investigator's brochures, periodic reports, expert reports, and global product labeling (package inserts, patient product information leaflets) and product monographs
  • Expert review of draft regulatory submissions identifying areas of vulnerability with respect to nonclinical data

    • REGULATORY AFFAIRS AND COMMUNICATION

  • Meeting preparation (i.e., briefing documents, rehearsals) and representation at FDA-industry meetings (Pre-IND; End of Phase I and II, Advisory Committee, Carcinogenicity Assessment Committee)
  • Evaluation of Need for FDA pre-IND consultation
  • Regulatory Consulting/Advising
  • Scientific Drug Development Consulting Advising
  • Gap Analysis/Needs Assessment
  • Determination of Preparedness
  • Risk/Benefit Evaluation

    • Pre-IND/IND (PDUFA) MEETING ACTIVITIES SUPPORT

  • Regulatory Consulting / Advising
  • Scientific Drug Development Consulting / Advising
  • FDA Communications
  • Project Team Management - Documentation Management
  • Scientific / Technical Writing
  • Compilation, publishing, submission to FDA
  • Attendance with Sponsor at meeting

    • REGULATORY OPERATIONS (SUBMISSIONS)

  • Project Team Management - Documentation and timeline management
  • Compilation, publishing and submission