Your pharmaceutical company can change millions of lives, but staff shortages among regulated companies in the life science industry often make it difficult to live up to full potential. When you need to increase productivity and decrease regulatory risks, regulatory services outsourcing provides an ideal solution.
At Regulatory Compliance Associates (RCA®), we offer a wide range of outsourced regulatory services to help you maintain your business operations — even after a compliance crisis or during a management turnover.
Regulatory Compliance Associates has the expertise to assist you with your unique regulatory needs. We understand that it’s not always government-regulated submissions or inspections our clients might need assistance with.
Outsourced Regulatory Services
In a competitive business world, pharmaceutical companies use regulatory agencies to often run lean on staff and resources. A staff shortage can slow normal business operations and make it difficult to deliver quality and timely solutions to your customers and end users. Instead, many companies choose to work with Regulatory Compliance Associates. for ongoing support or special projects where time and quality are of the essence.
With a team of more than 500 industry experts, Regulatory Compliance Associates can offer the assistance you need through large projects and management changes. You’ll find ongoing advice and support from an array of FDA consultant industry insiders who can help your business flourish as you successfully navigate stringent FDA guidelines.
We can assist Interim Management situations such as the company’s VP of Quality and Regulatory unexpectedly submitting their two-week notice, or another key QA staff member taking medical leave, or the start-up company needs strategic RA / QA insights, but isn’t ready for full-time headcount. Regardless of the size of the life science company, outsourcing quality and regulatory management can bring needed expertise while saving costs. We can provide outsourced management solutions to:
- Operations
- Quality
- Regulatory
- Medical Affairs
- Product Development
Perhaps you don’t need interim staff, but you’d like to teach your current staff and executives about regulatory communication or regulatory compliance. RCA also offers a broad range of assessment, support, and training services, including:
- Regulatory Gap Assessment
- Regulatory Due Diligence Audit
- Change Control Support
- Regulatory Affairs Training—Proper training is key in a regulated environment. We have a training program that suits your professional needs, company goals, and preferred learning style.
- Good Manufacturing Practice (GMP) Fundamentals
- Quality System Regulation
- International Medical Device Regulations
- Good Documentation Practices
- Quality Management Systems and Infrastructure
- Management Responsibility
- Risk Management
- Complaints and Medical Device Reporting (MDRs)
- CAPA and Root Causes Analysis
- Design Control
- Validation
- Environmental Control
- Calibration / Maintenance
- Purchasing Controls and Supplier Management
- Change Control
- Document Control
- Regulatory Submissions 510(k)
- Non-Conforming Product
- Technical Writing
- Audits
- Adverse Finding and Consequences
- Criminal Offenses
- Contributing To A Successful Quality Culture
- Electronic Submissions Preparation in Electronic Common Technical Document (eCTD) format for FDA, Health Canada, and EMEA
Transform your business with Regulatory Compliance Associates
Your pharmaceutical company has the power to transform lives, but you first need to stay within regulatory guidelines and maintain compliance with global regulatory authorities. If you’re looking for the best way to bring needed regulatory services to your business at an affordable cost, turn to the regulatory outsourcing experts at RCA® Inc..
About Regulatory Compliance Associates
Regulatory Compliance Associates (RCA®) provides healthcare consulting services to the following industries for the 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.
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