Our technology transfer specialists can work as a stand-alone project team helping you to maximise your resources by allowing you to concentrate on your core activities saving you time (and money), or we can embed ourselves in your existing technology transfer teams allowing you to optimise your resources in both the short and long term.
Through our wide experiences in technology transfer, we have developed a customisable risk based process that allows our customers to be confident of an efficient and successful transfer at any stage of the product development lifecycle.
We can help you navigate the complex requirements of technology transfer ensuring that you have the right help and resources for each stage of your project and by providing:
- Awareness of regulatory guidance’s
- Advice on technology transfer strategy
- Liaison with all parties and stakeholders to ensure smooth transfer process be it for a new or mature product.
- Request for CMO bid documentation
- CMO bid analysis and selection,
- Regulatory and technical gap analyses of the sending and receiving site
- Technology transfer planning and documentation
- Provision of advice and direction to avoid making common mistakes in technology transfer.
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Why choose Blue Hatch for Technology Transfer?
- Wide experience of technology transfer for most dosage forms including sterile products, biologics and novel dosage forms.
- Demonstrable experience in process troubleshooting.
- Team members have direct management experience of working within CMO’s.
- Our experts have worked with technology transfer of products from R&D through to full commercialisation.
- Using Chartered Chemists as well as engineers we ensure that we not only understand you process, but we also understand your product.
- Our validation, engineering and technical experts work together to provide you with a holistic service.
- We can work within your own technology transfer teams, or can provide a stand-alone project team.
- Can act as Subject Matter Experts for you for audits and regulatory inspections.
- Can act as an independent consultancy or as additional resource to your own teams.
- We are happy to work flexibly with clients; you only pay for what you want!