Screen Shot 2021 05 25 at 1 59 43 PM

One of the most persistent challenges for companies when it comes to regulatory operations is balancing the right level of support with the right skill sets, especially as the scope of operational functions has expanded over the past two decades.

Tracy Baldwin
Tracy Baldwin
PRA Health Sciences

Team members must have strong experience in their core operational function. However, as work ebbs and flows, it is equally important to have a team with ancillary skills in other critical areas who can take on cross-functional activities as needed. Even with the best information and planning, it can still be quite difficult to pin down the exact number and type of resources needed due to frequently changing corporate priorities or strategy adjustments. As the scope of regulatory operations broadens, the need for more varied technical skills in niche areas increases.

I often marvel at where we are today, especially as I think back to some two decades ago, standing proudly with my team for a photo in front of hundreds of paper binders reproduced in our copy shop. The lorries parked outside waiting to load those pallets of valuable data destined for the regulatory authorities who incidentally didn’t have the space to store them nor the time to paw through them! Once tied to a photocopier with Tipp-Ex and Paginator, we are now the masterminds behind submission strategies that facilitate the timely assembly of compliant regulatory dossiers for our key stakeholders and quality document delivery to agencies worldwide for review and approval.

Emerging submission requirements, data standards, and the evolution of product approval pathways have become ours to interpret and translate into proven strategies, not only to deliver against client goals but more importantly to get products to patients who need them.

As technology and data standards have advanced and submission validation criteria have been specified, we have responded by designing, developing, implementing, and supporting technology solutions that facilitate the management, interrogation, and availability of compliant regulatory information throughout the product life cycle. As curators of our clients’ data and documents, we enable powerful analytics that facilitate data-driven decisions and compliant data submissions.

As submission processes have become more complex and new registration pathways are introduced, it is more important than ever to engage highly skilled project managers who can effectively plan and manage risks to enable parallel, accelerated submissions. Regulatory project managers bring learnings and best practices, and they strive for operational excellence.

We’ve become veterans of transformation, living through multiple mergers and acquisitions. We’ve seen the pharmaceutical industry become more selective with the product portfolios they develop and manage. As a result, it has become increasingly common to see portfolios divested and acquired by other companies. When these portfolios transition, we deploy a team with direct therapeutic expertise who understand the submission nuances of the acquired markets and all aspects that impact licensing. Our project managers strategize and oversee the execution of these complex marketing authorization transfers, meet data transfer timelines, and understand the interdependencies of these multifaceted transactions that could include several buyers in multiple countries. In addition, we deploy our technology teams to execute on data migration, ensuring data integrity for the receiving company.

At PRA we have expanded our current Regulatory Operations group that was born in industry 15 years ago. A large number of our original team members remain with us today. We are proud of what we achieved within pharma, and we are excited by what we are delivering today from the CRO environment. Our services are highly responsive to our external environment and have evolved in line with business needs. Our experience is exemplified through case studies and our passion for client satisfaction shines through in our custom-built solutions.

Submission publishing and delivery remains at our core. However, we demonstrate value far beyond these operational activities, with newly created service lines according to our clients demands and an active interest in progressing technology and automation to bring opportunities for optimization and efficiency. Whether it is a custom solution of select services or our full end-to-end Embedded SolutionsTM, as a true partner we will simplify your staffing challenges by working with you. While respecting your individual needs and budget constraints, we can design the ultimate solution that gives you access to the right resources, at the right time, and allows you to leverage the shared knowledge and best practices of our broader team.

Curious to learn more about our capabilities?

Read more

Explore related content and topics