INC Research, a therapeutically focused CRO, has launched INC Research Strategic Advisory Services, a new global business unit dedicated to providing biopharmaceutical customers with world-class consulting capabilities in the areas of drug development and commercialization, regulatory consulting and submissions and quality assurance.

Through a new integrated services model, INC Research provides clinical expertise with extensive strategic advisory capabilities to help biopharmaceutical organizations mitigate risks, maximize resources and offer greater insight into product development lifecycles, commercialization opportunities and challenges.

“We’re excited to offer strategic advisory capabilities to biopharmaceutical companies in a more integrated way,” said Tim Dietlin, senior vice president of global consulting and strategic alliances, INC Research, and head of the new unit. “Working as an integrated team gives our expert advisors better visibility into our customers’ product development lifecycles and needs, enabling a true strategic partnership to evolve. This model allows greater flexibility and agility to identify opportunities, anticipate challenges and offer a broader range of perspectives and options for how to best address them.”

INC Research Strategic Advisory Services comprises three practice areas:

• AVOS Consulting— the company’s strategic management consulting division offers independent perspectives on the future business environment for healthcare products and services to pharmaceutical, biotech, device and diagnostic companies.
• Regulatory Consulting and Submissions— offers regulatory expertise across the entire lifecycle of small molecules, proteins (innovators and biosimilars) and devices. Teams and subject matter experts are located in multiple locations across the globe to maintain a global regulatory perspective for customers while leveraging local insights.
• Compliance Consulting — works with customers as an extension of their own quality assurance department to provide QA program management, including scheduling, preparing for and conducting audits, preparing and finalizing audit reports, reviewing audit responses and reconciliation, issuing audit certificates and more.

INC Research offers the full range of clinical development services to support product development from Ohase I to launch and beyond. Customers are able to fully leverage the company’s broad regulatory and development strategy expertise to find optimal claims and global regulatory pathways for their products.