API development
How to avoid the pitfalls
of pharmaceutical outsourcing
Outsourcing expert, Michael Gamlen, explains key issues
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 pharmaceutical outsourcing
Many pharmaceutical and biotech companies are looking for an expert team experienced in scientific and management leadership. They need a team who can confidently manage their entire drug development programme - from research to the pharmacy shelf.
We assess potential pitfalls and help you avoid them. We'll deal with the complex process of contractor selection and ensure you have the right expertise for each stage of the project.
We work with small and medium-sized companies wanting to develop their own product ranges. We help them develop products from scratch and advise on quality and regulatory issues through to manufacturing, packaging and labelling. We provide technical consultants to advise on best approach to take your product development into the commercial manufacturing stage.
Avoiding the pitfalls is all about:
• Selecting teams with right skills portfolio for each project area
• Building long term 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.
