Regulatory Business Process Services: A Strategic Enabler
According to 2014 estimates from the Tufts Center for the Study of Drug Development, it costs $2.6 billion to bring a new drug to market, a massive increase over the 2003 Tufts estimate of $802 million. To rein in expenses, companies have looked at various measures — from portfolio management and narrowing the therapeutic focus to seeking to outsource and partner with contract research organizations (CROs) and business process services (BPS) providers.
Achieving Cost Containment and Regulatory Savvy Through Partnership
Companies must also innovate to grow in a rapidly changing regulatory environment, where every stakeholder in the health ecosystem is becoming more tightly entwined. Part of this innovation requires embracing digital technology and the disruptions that come with it — new ways of thinking, innovating, collaborating and engaging with partners, affiliates and health authorities.
While the CRO model is widely accepted across the life sciences industry — with around 55% of clinical trials being outsourced2 — there is still room to partner more extensively beyond clinical execution. When working with a BPS partner, some companies see estimated savings of between 20% and 30% across regulatory submissions, product registrations, regulatory operations and affairs, and regulatory consulting and legal representation through more efficient and cost-effective use of compliant technology and proficient personnel.
BPS spans strategic consulting, business process development, technology expertise and document analysis — right down to the preparation of regulatory documents. Working with a BPS vendor gives companies access to validated systems, better marketplace insights, robust regulatory capabilities, well-defined business process know-how and around-the-clock support.
Plus, BPS providers bring an industry-wide, big-picture perspective that gives companies the knowledge and capabilities to strengthen their core competencies and even tap into new business opportunities while remaining compliant. When life sciences companies enter into a synergistic BPS partnership, they can gain more than the simple management of submission documents. The partnership can facilitate development and growth. It can draw on best practices, drive a flexible and scalable resource model, reduce overall corporate costs and harmonize processes and operations.