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. 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.
PDS will review your supply chain function using a top-down approach to ensure you’re obtaining all possible benefits from recent developments in lean manufacturing and supply – both for clinical trial materials and products. Our experts can assist you in identifying low cost, but reliable sources of API, products and packaging materials and put these together to help you maximise your return on product investment.
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.
PDS works 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.
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.
Reliable outsourcing – contractor management
PDS retains complete independence and accept no fees from any contractors. Successful contractor management is about establishing good relationships with key people at all levels within the UK and Europe and about having the right information about your supply chain available to help you make your decisions. An essential part of supplier management is auditing. Our staff are trained to audit against GMP, GLP, ICHQ7, ISO 9000 etc. We will carry out one-off audits for you, for supplier selection or to address a specific need, or we will design and manage a full audit programme for you. In all cases your QP will receive a full report and be able to make decisions with confidence.