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White Paper Optimizing Business Processes for Global Submission

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Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.

Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.

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White Paper Optimizing Business Processes for Global Submission

  1. 1. 1 OPTIMIZING BUSINESS PROCESSES TO DRIVE EFFICIENT GLOBAL SUBMISSION MANAGEMENT Ac6vi6es stemming from Regulatory Affairs tend to be cross-func6onal and global in nature. Many organiza6ons struggle with achieving excellence, reducing costs and increasing compliance due to lack of organiza6onal and process efficiencies. Several factors contribute to the complexity of Submission Management in a Pharmaceutical Company. (1) While Submission Management is traditionally “owned” by Regulatory Affairs, the content, data and infrastructure that support a Submission are owned by several other functions. (2) Consistently changing global regulations require constant upkeep and modification of business practices to ensure compliance. (3) Complex information landscape necessitates the optimal use of resources to set in motion simultaneous global submissions. To streamline the complex nature of Global Submission Management, Pharma must ensure they establish a robust organizational foundation based on sound business processes. Through these processes, roles and responsibilities are clearly defined, timelines for time- sensitive activities are established, hand-offs from one activity to the other are articulated, bottlenecks & risks are identified & mitigated and metrics & KPIs are put into motion to track and report outcomes. ✔ Roles ✔ Responsibili6es ✔ Timelines ✔ Hand-off’s ✔ Repor6ng ✔ Metrics ✔ KPI’s GAINING EFFICIENCIES WITH SOUND GLOBAL OPERATIONS AND AN EFFECTIVE REGULATORY SUBMISSIONS PROCESS
  2. 2. 2 Establishing the processes may seem daunting and costly at first, but once the optimal processes are in place, the long-term value, including increased compliance and overall cost reduction will be felt and appreciated over years to come. Furthermore, companies who have an established set of processes are in a great proactive position to quickly adapt to changing regulations in comparison to those who will be forced to be reactive each time a regulation changes. INVESTING TODAY FOR LONG-TERM VALUE CASE STUDY: 1572’S A large global Pharmaceutical Company, was anticipating an audit by the FDA for several of its time-sensitive submissions. They did not have visibility in the end-to- end process, were not able to track or report on the status of these submissions and were at risk of receiving a warning letter for non- compliance. The company required an assessment and optimization of the processes and supporting procedural documentation to ensure compliance with regulated submission timelines and a mechanism for tracking and reporting against those timelines. Some of the identified processes were cross-functional in nature and spanned multiple systems; alignment of functions and streamlining the fragmented systems was a key measure for successful delivery. Within 6 months of implemen6ng the op6mized processes the companies compliance rate was significantly improved; they were able to confidently report metrics, and saw a MEASURED IMPROVEMENT FROM A BASELINE OF 30% TO 96% COMPLIANCE RATE for their 1572 submissions. ONCE A COMPANY ESTABLISHES THEIR FRAMEWORK FOR COMPLIANCE AND ARE ABLE TO REPORT METRICS ACCORDINGLY, THE RISK OF WARNING LETTERS, COSTS OF INEFFICIENCIES AND LACK OF TRANSPARENCY IN THE ORGANIZATION AND CAN BE PUT TO REST.
  3. 3. 3 Regulations are consistently changing, and that constant churn will not stop, it is simply the nature of the global pharmaceutical landscape. Putting in place optimal processes today, ensures your organization is ready for the next set of regulation changes that are on their way. Companies who stall on change will find themselves in an unfavorable reactive situation, in which they establish business practices that are a “band aid” approach, and tend to be loaded with inefficiencies (intensive time constraints and cost and recourse overloads). STAYING AHEAD OF THE REGULATIONS AND YOUR COMPETITION CASE STUDY: 2253’S Companies who have an established proactive approach to optimizing their business processes have proactively transitioned from paper submissions to electronic submissions as early as 2011, today these companies are well positioned to proactively address the upcoming requirements of submitting 2253s via eCTD. Companies who are still submitting their 2253’s in paper will need to make a leap in preparation for the e-CTD requirements. ESTABLISHING A ROBUST PROCESS AND THEN PROACTIVELY MODIFYING THE PROCESS AS REGULATIONS CHANGE AND AS NEW TECHNOLOGY BECOMES AVAILABLE IS THE MOST SUCCESSFUL APPROACH TO MAINTAINING PROCESS EXCELLENCE. Companies who have a pro-active process culture have started to implement critical changes to their Data and Information structures in readiness for IDMP. CASE STUDY: IDMP
  4. 4. 4 For more information, please contact: Dalia El-Sherif, PhD Partner Pyxa Consulting Practice Lead delsherif@pyxasolutions.com 610-909-8831 Mike Swalina Partner Pyxa Operations Practice Lead mswalina@pyxasolutions.com 610-427-9570 Pyxa Solu.ons is comprised of a dynamic team of management consultants and R&D subject ma@er experts specializing in cross-func.onal R&D delivery stemming from ac.vi.es led by Regulatory Affairs Delivering over 100+ engagements In over 40 companies, Pyxa offers robust professional services in strategic and opera.onal business and technology solu.ons for the Pharmaceu.cal, Biotech and Medical Device industries Our opera.onal, strategic, consul.ng and technology services span across R&D with a focus on all regulatory special.es within and across the en.re product lifecycle, for both major and emerging markets ABOUT PYXA

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