Call for change

For life sciences companies, the smooth regulatory submissions to health authorities is business critical. Regulatory approvals grant permission to sell a drug or therapy with a specific dosage and strength for a particular indication in a specific country. Incomplete submissions delay product launches, and regulatory compliance violations can land companies in hot water. A company’s regulatory department oversees all applications and subsequent submissions, tracking what’s needed to be compliant in every country where it’s supplying the drug.

This is no easy task. Today, the printed documentation for a single drug’s new marketing application in one country would easily fill a tractor-trailer. Regulatory teams compile this information from all areas of the business—from early discovery reports to chemistry, manufacturing and controls (CMC) to labeling—a very complex process especially if the right documentation systems and processes aren’t in place.

A leading global pharmaceutical company recognized it could be even more efficient with a global view of regulatory demand. It lacked visibility into what documents were submitted where. For example, a local team in Brazil, may have to wait for global headquarters to share “core” submission documents before adding local materials and submitting. In the process, headquarters may not see what edits were made to the final submission to support consistency.

The company recognized that a unified regulatory content management system would streamline processes, reduce effort and increase transparency.

When tech meets human ingenuity

The company teamed with Accenture to consolidate four legacy systems and transition to Veeva Vault for Regulatory Information Management, a cloud-based solution. The platform and harmonized processes enable employees globally to readily access regulatory data, leverage workflows and see submission timelines using powerful search capabilities. For instance, if a manufacturer changes its address, the company will need to update and resubmit forms to regulatory authorities. A regulatory CMC team member could use the system’s powerful search capabilities to find all documents referencing the manufacturer.

Centralized data makes these capabilities possible. The system conveniently stores all initial application and subsequent change documents in one place. Workflows standardize reviews and approvals so users can track document timing, due dates and status. The system also allows users to view all submissions planned or in progress by product or country. In addition, external partners, regulatory authority auditors and various operations personnel can also be granted appropriate access to the system.

We knew employee uptake would be critical to the program’s success. Our change management approach helped key stakeholders understand how they will experience the new technology on a daily basis, and we developed role-specific training materials. We established a Change Agent Network made up of core business users, who received updates on the new platform and processes to cascade to their teams. We also identified super users for each function/region who benefitted from a more detailed walkthrough of the system and training materials so they could help their peers.

The RIM system Accenture implemented allowed users to view all submissions planned or in progress by product or country. It also enabled partners, regulatory authorities and personnel from the client, appropriate access according to their need.

A valuable difference

Easy document accessibility and workflows reduce the need for heroic efforts—users no longer need to spend hours hunting down information across systems. They can see at a glance who has yet to complete requested reviews or approvals, what’s ready to submit and what needs to be followed up to meet deadlines.

Robust reporting and dashboards give managers the insights to support simultaneous submissions across countries, which can help speed products to market for initial launches.

Insights into work volume support management decision-making regarding staffing and contracts. Teams also have more time to think about the regulatory strategy and content quality to support timely drug approvals.

Collaboration across all regions and functions, including external business partners and service providers, has also improved. The cloud-based platform improves data management and version control while reducing maintenance and running costs. Teams are reusing documents for submissions where regulatory requests are similar, say in Argentina and Chile, in order to reduce rework and improve productivity. This is key since once a product’s initial application is approved, updates and license renewals create a continuous churn of work across all the markets where it’s sold.

Enhanced collaboration also extends to compliance. The single, centralized platform reduces efforts to prepare and conduct inspections and audits.

With its transformed regulatory information management system and processes the company is speeding through approval milestones to get products in patients’ hands and help improve outcomes.

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