In today’s competitive business environment, life science companies run lean, particularly in terms of personnel. The regulatory affairs (RA) and quality assurance (QA) functions create extra complexity for life science companies because needs vary greatly depending on the life cycle of the organization. Early in the company life cycle, strategic leadership is needed for product filings, regulatory pathway, setting up manufacturing and creating quality management systems. As the company matures, these functions often transition to a maintenance mode.
Outsourcing strategic management can provide a better match to changing RA/QA strategic needs through the company life cycle. RCA’s interim management brings needed expertise while saving costs. RCA can assist in the following situations:
- Strategic leadership and management of the QA/RA functional area
- Staff transitions or augmentation
- Special projects lacking internal bandwidth
- Early stage companies needing strategic RA/QA insights, but not ready for full-time headcount
