Regulatory Response

FDA Consultants & Regulatory Response Services


Every day, as pharmaceutical companies go about their core business of developing breakthrough medicines to save lives and improve the quality of life of countless patients, the regulations they must meet continue to develop. It’s understandable that regulatory challenges, such as a warning letter, can arise for any size of pharmaceutical company.


Root Cause


What may seem like a localized issue that concerns one facility can actually have worldwide repercussions since critical drug shortages can be the result of even temporary production delays and plant closures. So, when a regulatory response does arise, finding the root cause of the problem and correcting it in the most efficient manner possible is clearly a priority for the pharmaceutical company, its stakeholders and the patients it can potentially help.


But if a company doesn’t know where to look for the root problem or how to address the warning letter in an effective manner, it can lose precious time and the lifecycle of the product can be detrimentally impacted.


RCA is Where Strategy Meets Success


After more than 20 years of experience helping pharmaceutical companies successfully navigate the regulations of the FDA and other agencies across the globe, we not only know how to look for causes of regulatory issues, but we also know where they typically occur. Most importantly, we know how to formulate a regulatory response strategy to correct them.


Warning Letter


Interestingly, for drug manufacturers, the most common warning letter problems that can lead to drug shortages typically occur in the supply chain. This is why it’s such a prudent choice to work with the team here at Regulatory Compliance Associates. We offer tailored pharmaceutical compliance and regulatory services throughout every stage of a product’s lifecycle.


Compliance Consultants


At RCA, we have a team of over 500 subject matter experts — including FDA compliance consultants and regulatory affairs specialists — who are well-versed in the intricacies of the pharmaceutical industry as well as the FDA’s modus operandi. We’re skilled at providing tailored support services to correct any compliance or regulatory issues you face throughout every stage, from research and development to manufacturing and quality assurance.


FDA Regulatory


We have a long list of pleased regulatory response clients, including new startup companies facing their first FDA regulatory challenges, Fortune 100 multi-national organizations looking to increase their market share, and even law firms in need of regulatory expertise when faced with challenges such as warning letters, import bans, 483s or consent decrees. This means when you outsource to Regulatory Compliance Associates, you’re not just getting a quality consultant — you’re getting targeted talent that’s up to the task.


Regulatory Action


If you’ve received a Warning Letter from the FDA or Notified Body, Regulatory Compliance Associates can develop a comprehensive program to address it and any other larger regulatory affairs challenges that may arise with your pharmaceutical product. We will provide a Project Management Professional (PMP) to lead the program, in addition to engineers with expertise in quality systems and manufacturing engineering to execute the program that coordinates with your resources.


FDA 483


Every situation is different and the program’s regulatory response plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies. Many of our consultants have experience in FDA-regulated industries and have the expertise to assist you with:


  • 483 Remediation
  • Pharma Warning Letter Remediation
  • Consent Decree Remediation


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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