About Us

Life Science Consulting & Regulatory Compliance Consulting

Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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, 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
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

The Scoping Process

Our Expert life science consultants have helped thousands of global clients of all sizes and can provide expert regulatory, compliance, quality, lab testing, and clinical support for your organization as well. This is a brief overview of our “Contact Us” website inquiry process to help you and your team better understand how our regulatory compliance consulting process supports clients from the start.

We’re responsive: Once you submit the information needed by our team in the blue form below, we’ll reach out to make email introductions and begin coordinating schedules for an introductory scoping call.

We’re comprehensive: During the scoping call, you will be introduced to RCA^® subject matter experts who will learn more about your company and discuss our life science consulting experience.

We’re confidential: Your business is just as important to RCA^® as it is to you. Our client conversations are protected by mutual non-disclosure agreements. It allows our life science consultants to talk freely during the course of business and how RCA^® can best support your needs.

We’re efficient: After the introductory scoping call, RCA^® will develop a proposed scope for your project and have a cost estimate with time & materials returned to you within an agreed upon period of time. A follow up proposal review call is next scheduled based on calendar availability to refine the project scope in real time. 

We’re global: Every proposal we develop is custom to the client’s needs and validated with the team before work begins. Every proposal considers how the international reach of the Sotera Health network can accelerate your business. The final proposal review call helps identify the total resources needed and priority of work. This ensures alignment between RCA^® and your team.

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 5,000 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 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.