1

OPTIMIZINGBUSINESSPROCESSESTODRIVEEFFICIENTGLOBALSUBMISSIONMANAGEMENT

Ac6vi6esstemmingfromRegulatoryAffairstendtobecross-func6onalandglobalinnature.Manyorganiza6onsstrugglewithachievingexcellence,reducingcostsandincreasingcomplianceduetolackoforganiza6onalandprocessefficiencies.

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

GAININGEFFICIENCIESWITHSOUNDGLOBALOPERATIONSANDANEFFECTIVEREGULATORYSUBMISSIONSPROCESS

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.

INVESTINGTODAYFORLONG-TERMVALUE

CASESTUDY:1572’SA 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.

Within6monthsofimplemen6ngtheop6mizedprocessesthecompaniescomplianceratewassignificantlyimproved;theywereabletoconfidentlyreportmetrics,andsawaMEASUREDIMPROVEMENTFROMABASELINEOF30%TO96%COMPLIANCERATEfortheir1572submissions.

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

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).

STAYINGAHEADOFTHEREGULATIONSANDYOURCOMPETITION

CASESTUDY:2253’SCompanies 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.

CASESTUDY:IDMP

4

For more information, please contact:

Dalia El-Sherif, PhD Partner Pyxa Consulting Practice Leaddelsherif@pyxasolutions.com610-909-8831

Mike SwalinaPartner Pyxa Operations Practice Leadmswalina@pyxasolutions.com610-427-9570

PyxaSolu.onsiscomprisedofadynamicteamofmanagementconsultantsandR&Dsubjectma@erexpertsspecializingincross-func.onalR&Ddeliverystemmingfromac.vi.esledbyRegulatoryAffairs

Deliveringover100+engagementsInover40companies,Pyxaoffersrobustprofessionalservicesinstrategicandopera.onalbusinessandtechnologysolu.onsforthePharmaceu.cal,BiotechandMedicalDeviceindustries

Ouropera.onal,strategic,consul.ngandtechnologyservicesspanacrossR&Dwithafocusonallregulatoryspecial.eswithinandacrosstheen.reproductlifecycle,forbothmajorandemergingmarkets

ABOUTPYXA