UK registration of a formulation of a big global brand, sourced from 3rd party CMO

A UK-based global CHC organization wanted to seek MA for a Fixed Dose Combination analgesic formulation. The product was sourced from a 3rd party CMO. Usually, the 3rd party sourcing is required when the in-house pipeline not able to support markets or when there is a local/regional business need for a client. For getting a product registered through a stringent regulatory authority like UK MHRA, 3rd party CMOs require consistent handholding to generate data as per the market requirement as well as a well-justified clinical rationale for biowaiver. The project team replicated its success model for global registration of drug products sourced from 3rd party (B2B) CMOs. A detailed review and gap analysis of the technical data received from 3rd party was carried out. The CMO team was directly communicated and guided step by step to generate the data/ plug the data gaps, thereby generating sound technical documentation, which helped compilation of dossier. At the end of the process, a comprehensive dossier for the drug product complying with “Well established route” requirements with sound biowaiver justification was ready and available for filing in the UK as well as many other markets. Thus DDReg could deliver a dossier that gained the client MAs in multiple countries. There were major costs and market advantages to its customer. DDReg’s effort was widely recognized within the customer organization.