Other Regulatory Services

What’s the client benefit result of choosing Regulatory Compliance Associates as a strategic partner? Organizations, especially emerging life science companies, maintain regulatory consulting expertise without the cost of a high-salaried employee. When you work with us, you get Executive Consultant support who make it their passion to know the latest changes in regulations so it becomes easier to successfully navigate warning letters, consent decrees and other compliance issues.


In short, you get the best in regulatory intelligence while paying for only the Regulatory Services you need. With appropriate pricing and best-in-class service, we offer the following regulatory assistance and training:


  • Combination Products
  • Combination Pharmacies
  • Regulatory Due Diligence
  • Staffing Support
  • Outsourced Regulatory Affairs
  • Regulatory Gap Assessment
  • Quality Culture Training
  • Regulatory Due Diligence
  • Medical Device Consulting


Small or emerging life science companies typically run lean, especially with personnel, often exposing themselves to quality or regulatory risks. However, for these companies, their stakeholders, and the patients whose health depends on the development of lifesaving drugs and medical devices, any delay in production can pose a significant setback, particularly when budgets and schedules are an issue. One solution Regulatory Compliance Associates® offers is to engage its regulatory services consulting experts for special projects and on-going counsel as needed.


With more than 500 Regulatory Compliance Associates® SMEs — all seasoned subject matter experts — to partner with, it’s never been easier to obtain the right advice and assistance to successfully navigate the strict and changing regulations that govern the pharmaceutical and medical device industry — like those from the U.S. Food and Drug Administration. Regulatory Compliance Associates®  is a skilled and experienced provider to life science companies throughout the world that need to find efficient resolutions to compliance and regulatory issues in the pharmaceutical, biologic, sterile compounding, biotechnology and medical device industries.


Whether you have received an FDA warning letter, are forming a remediation strategy, or are accelerating the release of a new product, when you have the right help on board, it can mean the difference between a successful rollout and a major crisis. This is why, regardless of where your company is in its product’s lifecycle when regulatory or compliance issues arise, you want the experience of a solutions-based enterprise like Regulatory Compliance Associates® in your corner. We’ve consulted on some of the most complex issues in the industry and our leadership has decades of FDA and regulatory experience.


About Regulatory Compliance Associates


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. 



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