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 industry
- Management of manufacturing, testing and clinical contractors
- Management of technical consultants
- Business development and management of pharmaceutical services business
- Manufacture 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 Europe
- Clinical 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.