Assisted Early Product Development Speeds Time to Market

Before any drug can go to market, factors such as chemical stability, solubility, dosing and the practicality of a proposed formulation must all be assessed. Early phase work can be extremely challenging and potentially demanding of time and resources, given all the unknowns that there are at the start of every project.

Most early phase projects are likely to involve elements of new method development, validation and stability. An experienced contract laboratory is often better placed and better resourced to carry out this work because of the balance of skills they can offer; science with compliance, project management, pragmatism in the laboratory and having experience of working with a wide variety of chemistries and formulations. Good communication, quality and flexibility of service are key in choosing the right contract laboratory.

Developing a stability-indicating method is never straightforward, especially for NCEs; reference materials and impurity markers are not always commercially available and the method developer has to be adept enough to provide the best ‘fit for purpose’ method under the constraints of time and cost.

As an experienced contract laboratory, RSSL can support these decisions and understands that choices made during development can have a major impact on time taken to market and potentially a lasting impact on sales and success. The company has helped accelerate time to market for many new products and enabled its customers to meet regulatory obligations with the minimum of fuss.

Reading Scientific Services Ltd (RSSL), +44 (0)118 918 4076 , enquiries@rssl.com, www.rssl.com.