The process of reviewing and selecting appropriate excipients and components to generate formulations that meet the target product profile.

Development and validation of stability-indicating analytical methods to adequately quantify various aspects of drug products.

Quantitative and qualitative assessment of brand leader products to enable development of the generic product.

Development of the manufacturing and filling process including definition of critical control parameters.

The generation of three batches of drug product that will be utilised to generate registration stability data and product characterisation studies and will be the formal batches for licence submission.

Formal studies to assess the stability of the drug product. This data will be utilised to allocate the product expiration date and also dictate storage conditions.

Production of drug product for use in human clinical trials. Pharmaserve NW holds the MIA (IMP) licence required for production of this type of batch.

Specific studies conducted to fully characterise the drug product. These studies assess areas such as required priming, cleaning requirements, robustness of the product, effect of resting and effect of temperature amongst others.

Submission of the Common Technical Dossier to the relevant regulatory authority associated with the ultimate market for the product, for example MHRA (UK), FDA (US).