For breakthrough product development, Pharmaceutical Quality System (PQS) requirements need to be followed while supplying suitable flexibility to suit accelerated activities for breakthrough product development timelines. Therefore, the accelerated development Pharmaceutical Quality System (PQS) strategy for each product will be unique, as it depends on the timing of the BT designation.
Image Credit: DS InPharmatics
A number of activities that might be considered to accelerate development activities are:
- Flexibility, on the basis of molecule, available product, and platform knowledge will be needed
- Just the activities with zero impact on patient safety or product supply should be delayed
- A quality risk assessment needs to be applied to every activity that will be delayed, and the rationale, and controls required to guarantee delayed activities are completed documented
- A number of activities that are usually completed before license application might need to be delayed and submitted:
- Post-submission, complete at inspection
- Post-inspection, before approval
- Post-market commitments
- The manufacturing readiness plan can be employed for the development of internal filing and inspection readiness checklists to safeguard all delayed activities are completed or addressed
- Any Pharmaceutical Quality System (PQS) deferrals need to be documented in a manufacturing readiness plan and monitored to guarantee completion
About DS InPharmatics 
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
In April 2021 we were thrilled to announce that DSI has just become part of ProductLife Group.
French-headquartered ProductLife Group (PLG) is well-known in the Life Sciences market. It has a track record of successfully managing global outsourcing programs and insourcing services for its international client base. The company is on a mission to help transform human health outcomes by optimizing regulatory affairs, safety & vigilance, and quality compliance for life sciences organizations worldwide.
The fit between our two organizations could not be more perfect. We will complement PLG's growing biotech services portfolio. US biotech sponsors recognize DSI as a leader in consulting for go-to-market strategies and RA pre-market consulting. At the same time, PLG has a strong reputation for managing end-to-end outsourcing of regulatory affairs and pharmacovigilance activities worldwide.
Our merger with PLG will harness our combined strengths, offering our clients on both sides of the Atlantic support with their developed drugs approvals and post-approvals compliance, plus advisory services on the best market strategies to deliver a rapid ROI on their development. Together we will offer our clients increased pharmacovigilance capabilities - including a QPPV; pharmacovigilance consulting; and a fully validated safety database - as well as complementary toxicology-related services; RIM/electronic document management services; and support for medical device regulatory requirements.
We see enormous potential in this new chapter for DSI and you, our clients. As a PLG company, we have the opportunity to become part of a global force in life sciences regulatory and compliance solutions and services, and we're incredibly excited to add our momentum to that effort.
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