Outsourcing 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 life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.
Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. Regulatory Compliance Associates® Inc.’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on-time, and within budget.
We offer medical device staffing support in the areas of:
To be successful in the field of medical device manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.
Our project management capabilities include:
- On-site Project Leadership or Project Management Support
- Design and Implementation of a Project Management Office
- FDA Workshops
- Project Assessment, Remediation, and Follow-up
- Advanced Schedule Optimization and Management
- Development and Implementation of Compliant Methods
- Risk Management
- Issues Resolution and Decision Tracking
- Change Management
- Performance Measurement and Tracking
- Tool Selection for Program Portfolio and Resource Management
Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add medical device professionals to your staff for a short- or long-term project through our medical device staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:
- Quality Assurance
- Regulatory Affairs
- Product Development
Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.
Project-Based Solution Implementation
When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. Our quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution and implement that solution for the utmost success in your project’s completion.
Cost-Effective Staffing Solutions
Medical device manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for their medical device outsourcing and staffing support and project management services.
Regulatory Compliance Associates® (RCA) provides worldwide 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-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.
- Founded in 2000
- Headquartered in Wisconsin (USA)
- Regional offices in Florida, Colorado and Europe
- Expertise backed by over 500 industry subject matter experts
- Acquired by Sotera Health in 2021