Outsourcing & Staff Augmentation
In this episode of RCA Radio, host Brandon Miller is joined by Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), to go over outsourcing leadership roles and how companies use staff augmentation to jump-start their project teams.
Listen in as we talk about what outsourced leadership and staff augmentation are by providing brief background and current trends in the industry. Then move on to talk about the process of augmenting your staff, the benefits, and why having a subject matter expert is critical in these types of projects.
RCA Outsourcing & Staff Augmentation Services
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.
All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA® has pharmaceutical consultants and medical device consultants that can develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.
To be successful in the field of 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 professionals to your staff for a short- or long-term project through our 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
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 outsourcing, staffing support, and project management services.
Our goal is to help you get your projects to completion on time and on budget — all while keeping superior quality at the forefront of your every task. And with a team of more than 500 associates and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.
About Regulatory Compliance Associates
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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. Our life science consultants 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
- 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.