Serving the Pacific Rim Bio-Tech Industry

Services

Our focus is to assist our clients with direction, protection, orientation and managing risk/conflict.

Our value-added business solutions for markets in Hong Kong, PR China, Japan, Taiwan, Vietnam, Thailand, Taiwan, Malaysia, Mongolia, Singapore and South Korea include:

  • Clinical Trial Management Services - MASH™
  • CLC bio’s bioinformatics applications and solutions – Next Generation Sequencing
  • Bioprocessing & Engineering Consulting
  • Inspection diligence services for cGCP, cGLP, and cGMP
  • Biochip-based biosensor technology
  • Business and commercial development services in the Asia-Pacific pharmaceutical and biotechnology sectors
  • Regulatory and resource mobilization services in the Asia-Pacific markets
  • Import/Export services for Branded and Generic Pharmaceuticals

Global Regulatory and Consultation Services

Dragon Bio- will facilitate the regulatory approval process for Sino and Pan ASEAN companies wishing to submit dossiers to European and North American and South American countries.

  • Global Drug Master File (DMF) Preparation and Maintenance
  • Investigational New Drug Application (IND), Amendments, Safety Reporting, and Annual Reports
  • New Drug Application (NDA), Amendments, and Supplement Annual Reports, and Post-marketing Reporting
  • 505(b)(2) NDA Application, Amendments, Annual Reports, and Post-marketing Reporting
  • Abbreviated New Drug Applications (ANDA), Amendments, Safety Reporting, and Annual Reports
  • Premarket Notification Application (510(k)) preparation
  • Certificate of Suitability
  • Clinical Trials Application (CTA)
  • Investigational Medicinal Product Dossier (IMPD)
  • Premarket Approved Application (PMA)
  • Investigational Device Exemption (IDE) preparation and maintenance
  • Prescription drug and over-the-counter drug labeling preparation
  • Orphan Drug Designation Request (ODDR) preparation and maintenance
  • Fast Track Requests preparation and maintenance
  • Biologics License Application (BLA) preparation and maintenance
  • United States Adopted Name (USAN) Application preparation
  • Product Registration
  • Establishment Registration

Preclinical Toxicology Consulting

  • IND Enabling programs
  • DMPK and TK programs

Clinical Pharmacology Consulting

Animal Disease models
  • Inflammation
  • Cardiovascular
  • Metabolic
  • Oncology
Animal Sourcing
  • Non-Human Primate
  • Canines
  • Rodent

Partnering

Dragon Bio-Consultants, Ltd. (DBCL) has an innovative approach for partnering with Chinese research institutions and pharmaceutical companies. DBCL identifies and helps conclude a license for the most promising pre-clinical and clinical stage compounds from the West and in China, leverages and extends the research efforts of its Western and Chinese partners, and provides a bridge into the international development process and global Biopharmaceutical market. Because many of the compounds have already been validated through a rigorous discovery, selection and development process in the West and in China, this model streamlines and accelerates development, while lowering risk. Moreover, the strength of DBCL's relationships with its Chinese partners ensures a continuous source of quality partnering opportunities for the future.

Import/Export

"Green Channel Activities"
  • Shanghai, Hong Kong, Panama
  • Generics
  • Pharmaceuticals
  • Biologics

Company Presentations

  1. Asia CRO Berlin
  2. Clinical Operations Summit
  3. EHR Adaptive Trial Design
  4. Orlando PCT 2012
  5. Vanderbilt Virtual Changes in Pharma