Regulatory Compliance Associates®
Life Science Consulting

Regulatory Compliance Associates (RCA) is widely recognized within the healthcare industry for regulatory compliance consulting and our life science consultants ability to help companies successfully resolve complex life science challenges.

By mining regulatory intelligence, our pharmaceutical consultants & medical device consultants continuously evaluate the global regulatory audience. We leverage thought leadership networks to advocate for our medical device, pharmaceutical, biologics, combination product, and compounding pharmacy clients.

About Regulatory Compliance Associates

Regulatory Compliance Associates (RCA) provides regulatory compliance consulting to the following industries:

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. Our life science consultants 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
  • 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. 

 

Medical Device Consultants

Our breadth of expertise in the Medical Device industry is globally renowned and in demand. Our services include regulatory affairs, assessments and audits, agency response, preparation and remediation, and strategic consulting on new product development support.

Pharmaceutical Consultants

Our background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory compliance, quality assurance, and remediation challenges, in addition to supporting strategic consulting needs.

Biotech Consultants

We have the experience and insights to guide biological products through the entire lifecycle. We help companies navigate complex regulations to increase their successful launch and steer them down the complex path of regulatory compliance.

How can we put our regulatory compliance Experts to work for you?


How can we put our regulatory compliance Experts to work for you?


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