Global BioSolutions
(Australian Biologics P\L)
ABN 35 089 700 149
PO Box 587
Craigieburn Vic 3064

Whats New

Regulatory advice and assistance

  • Explanation of FDA and international regulatory expectations and policies
  • Regulatory assessment and gap analysis
  • Due diligence of potential investment opportunities
  • Organization of meetings with regulatory agencies including FDA and European regulatory agencies
  • Guidance on communication interactions with regulatory agencies
  • Guidance on manufacturing and testing requirements
  • Guidance on pharmacology and toxicology requirements
  • Assistance in clinical trial design
  • Management of regulatory operations for smaller biotech companies
  • Management of regulatory project - major submissions
Regulatory submissions
  • Preparation or review of regulatory submissions
    • Pre-IND meetings or other meetings with regulatory agencies
    • US clinical trial applications (IND)
    • European clinical trial applications
    • Australian clinical trial applications
    • Other international applications
  • Assistance in responding to FDA or regulatory agency questions
  • Assistance in preparation of clinical trial amendments and annual reports
  • Preparation of Orphan Drug Applications
  • Preparation or review of Drug Master Files
Product development advice
  • Preparation or review of product development plans
  • Assistance with tech transfer of manufacture and test methods
  • Review of manufacturing and pre-clinical information
  • Project management
Contractor selection and management
  • Identification of manufacturing or test laboratories
  • Identification and assessment of experts or contractors
  • Preparation of Requests for Proposals from contractors
  • Review and assessment manufacturing and testing contractors
  • GMP and GLP audits
  • Negotiation with contractors on terms and conditions of contracts
  • Monitoring of preclinical studies
  • Review of batch and test records

December 08, 2005
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