Commercialisation

While a medicine is undergoing commercialisation, a Quality Management System (QMS) is required to:

• Support the scaled-up manufacturing process of the active drug substance and commercial medicinal product, to adhere to the company commercial manufacturing license
• Adhere to the post marketing obligations and Good Documentation Practice of the Marketing Authorisation Holder (MAH)
• Support the sale of a medicinal product from the MAH to its customers as licensed by a wholesale dealer authorisation.

Our expertise in supporting Pharmaceutical and Biotechnology clients during product commercialisation means we can support with the development and implementation of a QMS which adheres to Good Manufacturing Practice (GMP), including the qualification and validation of utilities, facilities, equipment and processes.

Some of the licences we have recently helped our clients with include:

• Medicines Healthcare Product Regulatory Authority (MHRA) MS Licence
• Medicines Healthcare Product Regulatory Authority (MHRA) WDA Licence
• Medicines Healthcare Product Regulatory Authority (MHRA) MIA Licence
• Medicines Healthcare Product Regulatory Authority (MHRA) licence to manufacture, import or distribute active substances