Regulatory Due Diligence

At Regulatory Compliance Associates, our team of experts help investors make better pre-acquisition decisions by executing regulatory due diligence, evaluating revenue expansion, and cost saving opportunities to help determine a target’s transaction value.


Due Diligence 


Previous clients have recognized Regulatory Compliance Associates® for offering the same investigative exercises that guide a Private Equity firm toward the proper judgment about proceeding with acquisition and how to negotiate the best deal price. We appreciate a refined approach to deal making and can you’re your entire deal team through each stage of the deal flow.


Regulatory Compliance Associates can help your team develop an integrated FDA viewpoint that lets Healthcare buyers develop a sensible viewpoint of the true story beyond the balance sheet. The regulatory due diligence benefit to your team is we’ll show you the asset value of what you’re buying, both tangible and intangible.



Regulatory Due Diligence


Environmental, Social, and Governance (ESG)


Environmental, social, and governance (ESG) investing is a set of standards used by socially conscious investors to conduct due diligence. Regulatory Compliance Associates has supported clients from around the world with their ESG programs and due diligence requirements. As sustainable investing continues to become more important in modern society, our regulatory consulting Experts can help you understand how to validate your environmental social governance strategy.


Further, the compliance process outlined in your environmental social and governance requirements can be accelerated by the due diligence consultant expertise Regulatory Compliance Associates provides. These are examples of ESG consulting services that RCA provides for global life science clients.



  • Supplier Quality Assessment
    • Do your suppliers follow the corporate ESG standards set by your company?
  • Compliance Assessment
    • Are workplace conditions for employee health & safety currently compliant with ESG guidelines?



  • Gap Assessment 
    • Does your company use accurate and transparent compliance processes for an ethical supply chain?
  • Internal Audit
    • Is your company accountable for following the mission & vision communicated to shareholders or investors? 



  • Change Management Assessment
    • How likely are your employees to pursue integrity during the product development or manufacturing process?
  • Transparency Assessment
    • Would your employees truthfully participate in a corrective and protective action (CAPA) program?


Since 2000, thousands of companies across the world have trusted Regulatory Compliance Associates® to care for their unique regulatory compliance needs. Our expertise is backed by more than 500 professionals, including FDA veterans and other subject experts who are here to guide you through every step of the regulatory compliance process. Whether you’re a Fortune 100 company or a small enterprise, trust Regulatory Compliance Associates to partner with you to tailor an ideal compliance services solution.


About Regulatory Compliance Associates


Due DiligenceRegulatory Compliance Associates® (RCA) provides due diligence consulting & consulting services to the following industries for resolution of life science 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, Regulatory Compliance Associates 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.


Commitment to Quality


Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.


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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