Health Pharmaceutical and Life Sciences (PLS) Regulatory Operations and Reporting

Pharmaceutical and life sciences (PLS) companies must execute a number of PLS-specific operational activities. These activities come at high costs and take focus away from critical activities that drive return. PwC wants to help you identify the areas of your business where you can realize value by leveraging managed services.

Market leaders are telling us:

They want to focus their people on differentiated capabilities and “drop” everything else
They are looking for "fresh" ways to lower cost
They are getting tired of “traditional” BPO plays focused on cost only and want innovation and value

PwC provides services across multiple PLS business areas and lifecycle phases. We work with you to analyze your company's value chain and organizational priorities to identify the opportunity areas that lower costs and drive value and return.

Leverage PwC’s individual managed services

Subject matter experts dedicated to supporting business unit goals
Highly tech-enabled platforms and tools to increase automation and efficiency
Pivot existing resources to higher-priority, “in-house” tasks
Lower costs, higher values and ROI

Co-source with PwC on multiple services

Centralized support team aligned with overall company goals
Collaboration based on trust and previous successes
Established contracting, deployment and escalation processes
Flexibility to scale

Compliance central

PwC supports the centralization, streamlining and operations of the end-to-end HCP engagement / management processes. PwC’s team of specialists and our HCP engagement product (Interactions Hub) digitizes and operates the end-to-end process to reduce risk, lower cost and create an exceptional internal and external stakeholder experience.

Learn more about HCP, HCO and Patient Engagement Managed Services

PwC’s team supports 100% of global spend transparency reporting requirements using our global transparency product (Transparency Hub). PwC can manage the entire data management process (collection, remediation and reporting) allowing organizations to focus on reviewing insights vs. performing time-consuming data management and reporting activities.

Learn more about Transparency Hub

PwC’s enterprise monitoring compatibility leverages compliance specialists with our analytics and monitoring engine (Risk Detect) to help you anticipate and mitigate risk across a variety of commercial, medical, research and development and quality compliance areas. Our team can help with the execution of risk assessments, creation and review of powerful analytics and execution of live and transactional monitoring on a global scale.

Learn more about Global Compliance Monitoring

PwC’s customizable, cloud-based portal consolidates all your customer interactions, ensuring you stay current and compliant. With real-time data accessible from anywhere, our system seamlessly integrates with your existing applications, creating a streamlined experience. Say goodbye to the complexities of cross-border transactions with our multi-lingual and multi-currency functionality. Automate contracts and payments, while gaining valuable reporting and tracking details. By freeing up resources through automation, you and your team can focus on high-value initiatives and activities and revolutionize your engagement process.

Learn more about Interactions Hub

Enterprise analytics

PwC’s enterprise analytics capabilities help you to centralize and streamline the collection and remediation of data to develop powerful analytics across commercial, compliance, finance, research and development and medical. Our team and technology can lower the costs while increasing the speed of analytics creation and our domain subject matter specialists can review the information to provide valuable curated insights back to the business.

Quality

PwC’s Quality managed services team provides a suite of services to address challenges and support your end-to-end quality transformation needs.

Complaints management: Manage the end-to-end customer request / complaint process, utilize automation to drive better customer support, leverage trends and analytics to drive continuous improvement
Document and batch record review: Support execution of document creation and change process, automate document tracking log, review batch records for errors, completeness and accuracy and escalate issues
eQMS model office: Provide oversight / collaboration across key areas for harmonization and support the ongoing validation needs
Metrics review: Aggregate data from multiple sources, conduct data analysis and reporting and support messaging across different management levels
Supplier management: Manage end-to-end supplier management process, drive consistent execution of supplier onboarding and review supplier performance to escalate issues
Additional QMS services: Provide technical expertise, support consistent execution and utilize a flexible support model to accommodate surges in workload

Regulatory

PwC’s regulatory services allow organizations to proactively plan and comply with an ever-evolving regulatory environment and set of global requirements. PwC provides managed services that compile regulatory submissions, conduct submission and labeling quality control, manage the end-to-end promotional material review process and regulatory operations program management.

Research and development

Operations management: PwC’s dedicated team and intelligent data analysis platform provides a central location where trial portfolio data is ingested, cleansed and consolidated into data visualizations and actionable trial management insights.
Intelligent trial design: PwC uses data-driven insights and real-world evidence to design trials specific to an organization that can decrease overall trial costs, shorten trial timelines and increase the likelihood of a trial’s scientific success.
Decentralized clinical trials: PwC’s team of subject matter specialists work to determine, design and conduct decentralized clinical trials that focus on enhancing the patient experience and streamlining the clinical trial process.
Centralized trial monitoring: PwC’s team automates routine trial monitoring activities leveraging data and our specialists can take on the execution of monitoring activities. This approach lowers the overall cost, better identifies potential risk areas for review and frees up capacity of internal resources to focus on higher value activities.

Revenue lifecycle management

PwC's team of subject matter experts and managed service professionals provide tech-enabled services to support requirements for commercial and government contract administration, government price reporting, rebates, chargebacks / billbacks and admin fee processing. PwC can manage the end-to-end process (data collection, validation and reporting) to support monthly, quarterly and annual reporting.

Third-party risk management

PwC’s TPRM team operates the third-party risk management program across the full continuum of risk domains (anti-corruption, cyber, privacy, ESG, compliance, etc.) tailored for the unique risks that face the PLS industry. PwC helps navigate the third-party / vendor landscape by providing third-party due diligence, current state assessments, program design and build-outs, as well as tech-enablement and continuous monitoring.

How we can help you take the next step

Perform rapid current state assessment

Quickly collaborate with leadership teams to identify areas where co-sourcing could add value and lower operating costs

Co-develop business case

Document findings from ideation phase and rapid assessment: value proposition, timelines for execution, immediate impacts and future state

Execute and implement together

Expedited transition and implementation phase with minimal impact to your team’s day-to-day activities and operations

Contact us

Nathan Lebowitz

Principal, Pharmaceutical and Life Sciences, Compliance Solutions, PwC US

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What if you had an end-to-end, tech-enabled managed services platform and trusted team? Contact us to start the conversation.

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