Interim Management: Outsourcing Quality and Regulatory Management
In today鈥檚 competitive business environment, life science companies run lean, particularly in terms of personnel.听 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鈥檚 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
RCA can provide needed expertise while saving costs in areas including:
- Quality
- Regulatory
- Operations
- Medical Affairs
- Product Development
Our broad range of Pharmaceutical Strategic consulting services include:
- Pharmaceutical Manufacturing
- Mergers and Acquisitions / Due Diligence
- Outsourcing & Staff Augmentation
- Change Management
To begin the Regulatory Compliance 黄人导航 scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.听You may also email us at [email protected].
