What are your biggest method development and validation challenges?
The strict timelines of drug development, often combined with limited internal resource, bandwidth, equipment, or expertise can mean that analytical method development and optimization is deprioritized. Ultimately, this can lead to methods failing further down the pipeline, increasing costs and impairing your ability to understand, control and optimize new products and processes.
Today, many of those working in pharmaceutical development face such challenges and limitations, meaning:
- Selecting and developing the right analytical method can be challenging, particularly when this demands an in-depth understanding of both the problem at hand and the fundamental measurement capabilities of the available analytical systems
- Mobilizing to ensure compliance with the ever-changing regulatory landscape and strict requirements from governing bodies can be difficult, increasing the risk of data rejection and threatening the successful submission of new products
- It can be difficult to keep abreast of the latest technological advances that could help you reach your next milestone
Amplify Analytics: a partnership between Malvern Panalytical and Concept Life Sciences, delivers unique services to help customers overcome method development and validation challenges:
We will work with you to help develop robust and fully-validated analytical methods that can either be implemented immediately in your lab.
Malvern Panalytical’s advanced analytical instrumentation and know-how, combined with Concept Life Sciences’ method validation expertise and comprehensive understanding of the regulatory landscape means:
- Our CRO experts can develop, optimize and transfer analytical methods, validating their performance in accordance with regulatory requirements – all under GxP controls if required
- Our integrated teams work directly with you to deploy the analytical methods developed specifically for your program, and implement the supporting instrumentation within your organization – providing the system validation, method transfer and targeted training you need to ensure your team can quickly access key data
- Our approach to project management is active and client-focused – each project is managed by a single point of contact, supported by a primary scientific lead and senior management research lead. This means our team helps you focus on the results, while KPI and budget tracking are also actively managed
In this way, we act as an extension of your own team, providing the expertise and support you need to rapidly and robustly deploy the right analytical methods, enabling you to concentrate on getting your product to the market faster.
To find out more about how the collaboration is helping our customers accelerate pharmaceutical development, watch our free webinar below.
What our clients say
“Very happy with the problem-solving, speedy response and engagement. This has led to direct improvements in API production with our two CDMOs as a result of the Concept Projects.”
CLS Customer, Pharmaceutical Industry
How can we help you develop robust and fully validated analytical methods?
To find out more about how our integrated team of experts can help you accelerate product development and speed up your route to market, contact us today.