Interim Management, or outsourced quality and regulatory management, has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the lifecycle of the organization. These companies turn to outsourcing to manage operations and tactical skills and also help adopt best practices.
Early in a company’s lifecycle, strategic leadership is needed for product filings, regulatory pathway, manufacturing setup, and quality management systems creation. As the company matures, these functions often transition to a maintenance mode. Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle. Our interim management brings needed expertise while saving costs.
We 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 QA / RA Insights, but Not Ready for Full-Time Headcount
We can provide needed expertise while saving costs in areas including:
- Medical Affairs
- Product Development
Additional Quality services include:
- Medical Device Single Audit Program (MDSAP) Readiness Audit
- Document Control Systems Implementation and Remediation
- Quality System Implementation
- Quality System Remediation
- Risk Management (ISO 14971)
- ISO 13485:2016
- 21 CFR part 820
- Quality Due Diligence
- Laboratory Support
- Standard Operating Procedure (SOP) Development
- Method Transfer
- Method Validation
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021
About Sotera Health
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.
We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.
To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.