Global BioSolutions
(Australian Biologics P\L)
ABN 35 089 700 149
19 Clovelly Drive
Craigieburn Vic 3064
Australia
globalbiosolutions.com 
Jim Ackland is the Managing Director of Global BioSolutions and has over 30 years experience in the manufacture, quality control, development and international regulatory requirements for biopharmaceutical products
Summary of expertise
Provision of technical and consulting services to the pharmaceutical industryManagement of manufacturing, testing and clinical contractorsManagement of technical consultantsBusiness development and management of pharmaceutical services businessManufacture and control of biological/pharmaceutical products including Australian and International Codes of Good Manufacturing Practices (cGMP), fermentation, microbiological and immunological assays, manufacture of final dosage forms as well as Bulk Active Pharmaceutical Ingredients.Registration of biological pharmaceutical products in Australia, New Zealand, USA and EuropeClinical trial approvals (IND/CTX) in USA, Australia, Europe, India and Africa.Preparation of Expert Reports (Chemistry, Manufacturing, Control and Preclinical Toxicology) for registration purposes.Development of pharmaceutical products - strategic planning of product development, preparation of clinical trial strategies, design and management of pre-clinical safety (toxicology) programs, approval of development reports and assessment of new product opportunities.Commercialization of pharmaceutical products - preparation of the commercialization plans of pharmaceutical products, preparation of international registration strategies, commercial negotiations with potential international customers.http://www.globalbiosolutions.com/consultants.html |
