We have been involved in projects where we have been selected to provide support on a particular service; i.e. to manage and have oversight of its wholesaling activity, to manage the pharmacovigilance activities, to act as QPPV etc. While, the same company outsourced many other functions including the manufacturing and batch release to market activities.
The CMO could have an excellent manufacturing history and be renowned for developing new products. The regulatory service provider equally is renowned for achieving the marketing authorizations (licence) quickly. However, what we often find is that the flow of communication between the different outsourced partners can be flawed and vital pieces of information can be overlooked or forgotten.
- What if the pharmacovigilance team are not made aware in a timely manner of a new product licence being approved?
- Are the Regulatory team aware of the Pharmacovigilance requirements?
- What if the contract manufacturer fails to inform the regulatory team about a new supplier?
- What if you have a critical / non-critical complaint from the market, who is responsible for coordinating the team to investigate the issue? Does it require notification to the health authority? Who will take responsibility for communications?
- Where does the responsibility lie where there is a cross over between service providers e.g. eCTD submissions by Regulatory Service Provider for PSUR prepared by PV Service provider.
The advantages of outsourcing to one service provider:
When a single service provider is involved in managing your entire product lifecycle, there is less risk of inconsistency. This is because the single service provider will appoint a single team of experts responsible for all aspects of the product registration process, pharmacovigilance and quality. This team will have a deep understanding of the project scope and expectations of the client, and also will be able to work together more efficiently to ensure the timelines and budgets are monitored and adhered to.
Reduced costs & Time:
Outsourcing to multiple service providers can be expensive, requiring the licence holder to manage multiple contracts, ensure they are frequently audited to the relevant standard, when they themselves are not qualified to perform such audits. Each service provider may have a different pricing structure, making it difficult to create and maintain a cohesive budget. By selecting a ‘reliable ‘one stop shop’, more of your time can be freed up to get on with the next phase and less time spent on the dreaded administrative burden’. It also allows you to work with one dedicated Project Manager which will ultimately lead to increased predictability.
Your product deserves a partner as passionate about its success as you are. At Acorn Regulatory, that’s a challenge we take seriously. We are a privately-owned, full-service provider operating globally that’s committed to being the best in the world as measured by our employees and our customers. We work as tirelessly for your product as you do.
