Services

Regulatory Strategy and Operations

  • Provide drug development guidance and regulatory strategies
    — Adherence to FDA, ICH regulations, and Health Authority regulations
  • Facilitate regulatory communications and meetings
    — Draft FDA Correspondence
    — Conduct FDA Mtgs (e.g. Pre-IND, EOP2, Type A, B, or C Mtg request)
  • IND drafting, compilation, and submission (eCTD and electronic submissions)
    — IND Maintenance and Annual Reports
    — Amendments, Updates, and Requests for Information
  • Orphan Drug Designation Request/Office of Combination Products
  • Medical Writing (briefing packages, INDs, Annual Reports, Protocols & Amendments)
  • US Regulatory Intelligence Database

Clinical Development/Medical Feasibility

  • Clinical Development Plan (Clinical Ph 1-4 study sequence and milestones)
  • Drug Development Plan (Regulatory, CMC, Clinical plans)
  • Protocol synopsis
  • Drafting full clinical study protocol (ICH, eCTD compliant)
  • Drafting interim and final study report (CSR)
  • Clinical study vendors identification and negotiation

NonClinical Services

  • Construction and Review of Nonclinical Program
  • Nonclinical Vendor Identification
  • Nonclinical Study Protocol Review
  • IND-enabling guidance, preparation, and drafting of nonclinical summary
  • Toxicity assessment to support clinical dosing and safety
  • ADME, Pharmacokinetic, and Toxicology planning and review

CMC and Quality

  • Drafting and review of all CMC regulatory documents and reports
  • CMC Development Plan – Navigating Phase Appropriate Readiness
  • Contract Manufacturer Assessment and Review (GMP)
  • API qualification guidance
  • Final formation, packaging and labelling support
  • Analytical testing/Environmental monitoring review
  • Stability Program Development
  • Technology Transfer Planning
  • Site Audit and Qualification
  • Quality by Design Process