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PHARMACEUTICAL SERVICES |
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| Outsourcing
offers you scope to expand your capability without increasing costs. It
saves you money on in-house activities and reduces your time to market. Keys to successful outsourcing Many pharmaceutical and biotech companies are looking for specialists with a rare blend of scientific and management leadership. They need an experienced team who can confidently manage a complete drug development programme - from research to market. We know the pitfalls and will help you avoid them. We'll deal with the complex process of contractor selection and ensure you have the right people for each stage of the project. We work with small companies wanting to develop their own range of products. We help them develop products from scratch and advise on quality and regulatory issues through to manufacturing, packaging and labelling. Avoiding the pitfalls is all about: • Selecting teams with right skills portfolio for each project area • Building long term trusted relationships • Knowing where to find the best people • Ability to examine a portfolio of products and know technical issues likely to cause problems PDS was set up specifically to provide a full outsourcing service to businesses from all over the world needing product development work done in Europe. CRO selection training to reduce your risks One of the biggest challenges facing clients is finding people with the right skills and expertise. This is where we can help you resolve complexities of CRO selection. Our in-house training and mentoring is designed for individuals and groups. Training includes recommending SOPs and systems to limit your liabilities and receive value for money. All our recommended contractors are scrutinised to ensure quality and compliance standards are maintained. We prepare costs based on accurately identified requirements, then commission and manage contractors through each step of the process. Clinical trials product manufacturing We'll assist you with pharmaceutical product development from Phase 0 to Phase 3 clinical trial material manufacturing to packaging and labelling. Our services include: • Making your projects more successful by developing contractor's expertise • Managing packaging and supply for studies from Phases 1 to 3 • Carrying out study-related compliance audits, and following-up with contractor to ensure continuous improvement New product introduction management You might want to import new products from outside the European Union. We'll explain what you need to do and advise on regulatory and quality issues. Our QPs will advise you on licensing and releasing products for manufacture. We also provide technical consultants to advise on best way to take your product development into the manufacturing stage. We'll advise on packaging ideas to improve product formulation and manufacturing strategies to address products with specific difficulties. We can advise on marketing and best ways to present packaging for global supply - ensuring your commercial goals stay on track. Technical due diligence Technical due diligence can be undertaken for potential licensing opportunities. We'll carry out a detailed review of the financial, management and operational aspects of a project. This can be extended to chemistry, manufacturing and control, preclinical and clinical due diligence by associated PDS experts. The transfer of product knowledge from licensor to licensee can be facilitated. An assessment of the science and technology underpinning a licensing opportunity is an essential first ingredient for informed decision making. Typical questions include: Has the best technology been selected for this product? Is it practical and effective? Is the technology based on sound scientific principles? Is the manufacturing process scaleable and commercially viable? What are its strengths and weaknesses? What could go wrong? Benefits of technical due diligence include: • Informed decision making • Independent analysis • Reduced risk • More accurate valuations • Stronger negotiating position • Identification of alternative or complimentary technologies • Fewer bad investments • Focused market opportunities International product launch Our team will advise and manage relationships with key people in all areas of supply chain, particularly the difficult area of pharmaceutical product release and distribution. And ensure stock requirements and supply forecasts enable a trouble-free roll-out. |
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© 2008 Pharmaceutical Development Services Limited. All Rights Reserved. Pharmaceutical Development Services Limited The Surrey Technology Centre, 40 Occam Road, The Surrey Research Park Guildford, Surrey GU2 7YG, UK Tel +44 1483 685420, Fax: +44 1483 685421 Registered in England and Wales, Number 4476828 VAT registration number 761 1430 60 |
