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
