Dt&SanoMedics

Strategic Consulting
& Regulatory Services

Unrivaled Quotation process for
Strategic Consulting.

Non Clinical Trial and Early Phase

: We try to find out client’s market access strategy
like regions, licensing strategy, and so on.

  • Non Clinical Trial
    Consulting

  • Global Regulatory
    Consulting

  • Licensing
    our strategy
    consulting

Dt&SanoMedics & Dt&CRO
Collaboration

The protocol is the foundation from which all clinical study strategies are built.
To ensure our proposed strategy aligns with client's objectives, market access strategy and budget, our team identified several project-specific considerations that could potentially optimize the conduct and results of your study.

Client Meeting (With Free of Charge,
With Medical Doctor)
Finding Client’s Strategy
  • License In&Out
  • Final Market Access
  • Regulatory Strategy
Proposal Suggestion (With CV)
Based on expecting SYNOPSIS
  • Project Management Group
  • Site Selection
  • Site Feasibility plan
  • PI Selection
  • Regulatory Strategy
  • Pharmacovigilance Strategy
  • DM/STAT Strategy
Futuristic Strategy Deduction

Our experts are fully committed to providing you with the best plan & strategy for the whole process. From development stage to product approval, we can cover your every complex affair with regulatory capability and extensive experiences. We offer full coverage at all healthcare areas including pharmaceutical products, medical devices, and health functional foods. With one-stop service for every development stage, our Regulatory Affairs team helps you handle regulatory workflows faster and efficiently. (Let us support you with multiple perspectives managing products throughout complete regulatory lifecycle and provide expert regulatory management and consultancy services to meet your complex.)

  • IND, IMPD, AUS IRB, & Global Clinical Trial Application
  • NDA, BLA, ANDA, 505b(2), MAAs, Generics, DMFs
  • Dossier Review for special drug: Orphan Drug, Biosimilar, Fast Track, Breakthrough
Application & Dossier Maintenance,
Review for each CTD Section
  • eCTD Writing and Registration
  • SEND Pharmaceuticals / Biologicals / Cell therapy / Herbal medicines
  • NCE (New chemical entity) / IMD (Incrementally modified drug) / Generic
  • Safety & Efficacy review / S&TM (Specification & Test Method) review / GMP data review
  • CMC Consulting
  • Pharmacovigilance / RMP
  • DMF (Drug Masater File)
Non-Clinical Management and Consulting
  • Non-Clinical Strategy
  • Study Lab Identification, Non-Clinical Study Set up, Study Monitoring
  • Review and Writing of Non-Clinical Reports (Module 4)
  • Gap Analysis for Non-Clinical trial results (with Global company)
  • Writing of Module 2.4, and Module 2.6
Drug Development & Strategic Consulting
  • Product Pipeline Development and Consulting
  • Registration & Pipeline Development Strategy
  • Regulatory Scientific Advice and Consulting
  • Agency Strategy and Interaction
  • Pre-IND Consulting
  • FDA/EMA Advisory Committee Meeting Support
  • CTD Packaging and Full writing