The combination of a lengthy process and high cost of drug development is a hard pill to swallow for pharmaceutical companies. It should serve as the biggest motivation for them to find fundamental ways to accelerate their overall time to market.
“Based on my 20-plus years of experience in the pharmaceutical industry, I have seen a variety of obstacles that result in delays to registrations, many of which can be avoided by using sound business processes and leveraging technology to automate processes,” said Patricia Santos-Serrao, MasterControl’s director of pharmaceutical and biologics solutions (1).
Santos-Serrao identified the most common problems in product registration and submission management in a new white paper. She also shared some tips on how to address them.
If you’re involved in regulatory affairs, product registrations, and submissions, beware of the following problems, which tend to be more pronounced among companies with manual processes.
#1 Drowning in Documentation: Registration requires a complex compilation of a variety of information coming from various functional areas. Recalling her years in regulatory operations, Santos-Serrao said her team was inundated with paperwork. Documents with wet signatures used to arrive through the mail. Documents without signatures arrived via email and fax. “They were essential documents that went into a regulatory submission and often repurposed globally across various country submissions and registrations,” she said.
Today the Common Technical Document (CTD) format is widely accepted for organizing submissions. Pharmaceutical and biologics industries have adopted the electronic CTD (eCTD) standard globally, but some countries have not. “If your organization still manages submission content manually, it’s high time to consider automating your process,” said Santos-Serrao. She’s part of the development team behind MasterControl Registrations for eCTD, a cloud-based product registration and eCTD management solution.
#2 Lack of Control: Regulatory affairs (RA) professionals manage submissions but they usually see the contents after they are approved by other teams responsible for functional areas. Worse, manual tools put RA professionals at the mercy of the other teams. Without the proper tools, they lack control of the process.
Santos-Serrao said to minimize last-minute activities, regulatory operations must be proactive. They must collaborate with other stakeholders and enforce the use of document templates for document formatting to ensure that the content provided for submissions are indeed “submission ready.”
#3 Lack of Transparency: RA professionals are responsible for addressing requests for information and clarification from regulatory agencies and disseminating those requests to the relevant departments to obtain responses. Scattered resources and contributors can lead to process delays, overlooked tasks, and missed deadlines for activities such as turnaround on request for information, annual reports, re-registrations, and periodic updates. Santos-Serrao said an automated and centralized platform for all information is necessary to bring about greater transparency of activities and artifacts that will impact a product registration.
#4 Ineffective Project Management: Still using a spreadsheet to manage registration projects? The problem is it doesn’t scale to the complexities of managing regulatory requirements, changes, and timelines. Tracking requirements impact not only one registration but all registrations. RA and submission managers need the capability to see what activities and information are relevant to a product and what impact they have on registrations. When something changes, they would immediately know which registrations may require updates.
“In lieu of the archaic spreadsheet, choose a software solution with powerful project management tools, such as dashboards, checklists, analytics, and links that will provide insight into all registrations and associated content,” said Santos-Serrao. A switch to an automated system is a necessary first step to improve the product registration and submission management process.
Santos-Serrao praised the pharmaceutical, biologics, and biotech industries for delivering some of the most innovative life-saving and life-sustaining products that exist today. “The world cannot wait to benefit from these products due to inefficiencies in business processes,” she added.
Cindy Fazzi writes about the life science industry and other regulated environments for MasterControl. She has worked as a journalist in three countries. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York City. She has a master’s degree in journalism from Ohio State University.