The Role of Regulatory Tracking Software in Accelerating Drug Approval Processes

In order to distribute the products, pharmaceutical manufacturers must ensure compliancy with global and local regulations and provide the required testing and reporting to validate products, their safety, and accurate labelling specifications.

Within this challenging environment, organizations are counting on Regulatory Affairs (RA) staff to track and manage product registration requirements on a constant basis. Monitoring national, federal, state and local regulations is a challenging task for the RA team. Juggling pre-registrations of new products, re-registration of products from M&A activities, and managing and updating existing registrations on a bi-annual or annual basis is difficult enough domestically. The complexity of monitoring international regulatory requirements in over 100 countries, leads to a situation with a high probability of errors and missed deadlines leading to distribution delays and possible missed revenue.

The product registration process and the constant communication and tracking of deadlines takes a considerable amount of time and effort. Pharmaceutical companies are also subjected to many inspections by government agencies. As part of the audits, observations are made in the following areas: production, packing and branding material; laboratory controls, quality, and the facility. Companies are constantly looking for new ways to streamline the registration tracking process.

Changes in design, packaging and labeling requires an organization to re-register a drug and corresponding ingredients. Since this information is often stored in spreadsheets and paper-based files, updates may go unnoticed by RA employees who are not part of the process. Lack of visibility into regulatory processes can result in compliance issues, fines, quarantined product and lost revenue. By integrating all regulatory data into one central repository, email alerts and notifications can be sent to RA managers to update existing registrations.

Regulatory Tracking Software is a centralized platform designed to support and streamline Regulatory Affairs teams and operations. It is a growing software category that streamlines the submission of human medical products—including pharmaceuticals, biologics, and medical devices to regulatory agencies, ultimately to gain authorization to sell the said product in a given market.

New software technologies help RA managers manage the activities of internal team members and third party affiliates to ensure everyone is following the correct procedures, performing the necessary tasks and meeting deadlines. The software helps in the creation, organization, submission, and archival of regulatory information in regulated formats. It allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product’s complete life cycle.

Systems and Data Integration: An ideal function for a product registration tracking solution is that it should integrate with a manufacturer’s core business systems – such as an ERP, CRM, or MES – and automatically pull the required data for product registrations. This allows for the RA manager to quickly and accurately fulfil regulatory requirements. It eliminates the need for manual data entry and ensures that regulatory affiliates are using accurate, consistent and up-to-date information when registering or re-registering products, or making changes to existing product registrations.

Increase Productivity & Cost Efficiency: Through process automation and data consolidation, RA professionals can eliminate most of the manual tasks currently associated with the product registration process, reducing administrative costs and enabling them to reassign resources to more value-added activities within the organization. When the organization knows exactly which product registrations are due at what time, RA professionals can evaluate the available resources in those markets, determine the necessary manpower for meeting upcoming deadlines and assign necessary resources.

The Regulatory Tracking Software System:

1. manages product dossiers including regulatory product information,
2. aids in the preparation of product submissions in regulated formats, and
3. manage the submission of information in approved formats to regulatory agencies.

Vistaar is an effective regulatory tracking software, that:  

1. Provides clear oversight of original and lifecycle submissions
2. Provides appropriate support for the firm’s size and complexity
3. Helps to stay ahead of the game and remain compliant with the comprehensive regulatory tracker for the pharmaceutical industry
4. Tracks statutory and regulatory changes across global countries and compile their findings into an easy-to-use resource
5. Minimizes effort and calendar time to replicate regulatory submission between products and regulatory agencies
6. Helps in streamlining regulatory compliance for smoother operations
7. Helps to easily meet upcoming national regulations on serialization of drugs to ensure patient safety
8. This tracker provides an editorially curated resource for attorneys representing drug companies who need to monitor regulatory activity affecting their clients. In addition to summarizing regulatory activity, this tracker features action items for attorneys including effective dates and compliance dates, deadlines for submitting comments in response to proposed rules and draft guidance, and other key information