Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to an FDA finding, Regulatory Compliance Associates team of compliance consultants can help. Our business consultant Experts are internationally known in the regulatory compliance consulting industry.


Compliance Consulting Services


The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced compliance veteran. If you’re consistently unable to comply with regulations, any notified body can deliver devastating consequences for your business. At RCA®, we offer the pharmaceutical consultants & management consulting resources necessary to guide you in regulatory compliance.


We’re In Compliance


From family-owned enterprises to multinational Fortune 100 companies, we work with all types of pharmaceutical businesses. RCA® Inc. is a certified ISO 9001 organization: we understand navigating the changing demands of FDA, MHRA, Health Canada and other regulatory agencies.


Over 500 industry experts, FDA veterans and consulting professionals oversee our services to ensure that your business is protected to the fullest possible extent. Regulatory policy is what we do – and we do more of it than anyone we know. 


Regulatory Compliance Solutions


We offer the following pharmaceutical compliance services to keep our clients out of non-compliance:




The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our FDA compliance consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.


Our range of compliance consulting services include:


  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.




Periodic regulatory audits are necessary to both ensure the continued compliance of your organization. An internal audit from a 3rd party business management consultant can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA certified auditors is available to perform a range of internal audit services, including:


  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products


Regulatory Agency Response 


Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. RCA’s strategic consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:


  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans


Preparation, Training, and Inspection Readiness 


Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections and other medical consulting readiness solutions:


  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations


About Regulatory Compliance Associates


Regulatory Compliance Associates (RCA) provides pharmaceutical consulting 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, 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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