Strategic Consulting & Regulatory Services

Unrivaled Quotation process for Strategic Consulting.

Non Clinical Trial and Early Phase

Your market access strategy first

We try to find out the client’s market access strategy, such as regions, licensing strategy, and so on.

Dt&SanoMedics & Dt&CRO Collaboration

  1. 01Non Clinical Trial Consulting
  2. 02Global Regulatory Consulting
  3. 03Licensing our strategy consulting

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.

Quotation process

From first meeting to strategy

  1. 01

    Client Meeting

    Free of charge, with a medical doctor

    Finding client’s strategy

    • License In & Out
    • Final Market Access
    • Regulatory Strategy
  2. 02

    Proposal Suggestion

    With CV

    Based on the expected synopsis

    • Project Management Group
    • Site Selection
    • Site Feasibility plan
    • PI Selection
    • Regulatory Strategy
    • Pharmacovigilance Strategy
    • DM/STAT Strategy
  3. 03

    Futuristic Strategy Deduction

Regulatory Affairs

From development stage to product approval

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 the complete regulatory lifecycle and provide expert regulatory management and consultancy services to meet your complex needs.

  1. IND, IMPD, AUS IRB, & Global Clinical Trial Application
  2. NDA, BLA, ANDA, 505b(2), MAAs, Generics, DMFs
  3. Dossier Review for special drug: Orphan Drug, Biosimilar, Fast Track, Breakthrough

Application & Dossier Maintenance, Review for each CTD Section

  1. eCTD Writing and Registration
  2. SEND Pharmaceuticals / Biologicals / Cell therapy / Herbal medicines
  3. NCE (New chemical entity) / IMD (Incrementally modified drug) / Generic
  4. Safety & Efficacy review / S&TM (Specification & Test Method) review / GMP data review
  5. CMC Consulting
  6. Pharmacovigilance / RMP
  7. DMF (Drug Master File)
Reviewing printed documents at a desk

Non-Clinical Management and Consulting

  1. Non-Clinical Strategy
  2. Study Lab Identification, Non-Clinical Study Set up, Study Monitoring
  3. Review and Writing of Non-Clinical Reports (Module 4)
  4. Gap Analysis for Non-Clinical trial results (with Global company)
  5. Writing of Module 2.4, and Module 2.6
Researcher in a lab coat using a tablet

Drug Development & Strategic Consulting

  1. Product Pipeline Development and Consulting
  2. Registration & Pipeline Development Strategy
  3. Regulatory Scientific Advice and Consulting
  4. Agency Strategy and Interaction
  5. Pre-IND Consulting
  6. FDA/EMA Advisory Committee Meeting Support
  7. CTD Packaging and Full writing
Hand holding a capsule with a DNA graphic