Acquisition strengthens Sotera Health’s quality, regulatory, and technical consulting capabilities

 

CLEVELAND, OH  November 9, 2021 – Sotera Health, a leading global provider of mission-critical sterilization and lab-testing and advisory services announced today that it has acquired Wisconsin-based Regulatory Compliance Associates (RCA). This acquisition expands the US-based quality, regulatory, and technical consulting capabilities of Sotera Health. RCA is an industry leader in providing life sciences consulting focused on quality, regulatory, and technical consulting for the pharmaceutical, medical device and combination device industries. Terms of the deal were not disclosed.

 

Headquartered in Pleasant Prairie, Wisconsin, RCA has extensive industry knowledge through a network of in-house and external experts and is known for its best-in-class solutions. Founded in 2000, the company has grown to be nationally recognized for its tailored, solution-driven approach to compliance related issues.

 

“Regulatory Compliance Associates is a premier provider of quality and regulatory services; known for its best-in-class solutions. It is also recognized for its strong relationships with its customers and regulators,” said Michael B. Petras Jr., Chairman and CEO of Sotera Health. “This acquisition will expand and further strengthen our technical consulting capabilities. We welcome RCA’s strong management and expert staff as they join us in our mission, Safeguarding Global Health®.”

 

“Our mission is to provide our customers with unsurpassed technical expertise combined with quality service. We have earned a reputation for our customer service and are seen as an essential partner for our customers—and we know we have found the same in Sotera Health,” said Erika Porcelli, CEO of RCA. “My goal for RCA is to continue our commitment to serve customers supporting their regulatory and compliance needs as they bring critical pharma and medical device products to market. We accomplish this by becoming part of Sotera Health, a global company whose breadth of services and expansive reach provide extraordinary value to the industries we are proud to serve.”

 

Regulatory Compliance Associates’ consulting capabilities will complement and enhance Sotera Health’s existing strengths in technical consulting and expert advisory services. Regulatory Compliance Associates is ISO 9001 accredited.

 

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 is a leading global provider of mission-critical sterilization 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 millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.  

 

Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.

 

About Regulatory Compliance Associates

Regulatory Compliance Associates® Inc. (RCA), is a life sciences consultancy focused on quality, regulatory, and technical consulting headquartered in Pleasant Prairie, Wisconsin with offices in Colorado and Florida.  RCA provides worldwide services for the resolution of compliance and regulatory challenges to the Pharmaceutical, Biologic & Biotechnology, Sterile Compounding, and Medical Device industries.  We understand the complexities of running a life sciences 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 and globally regulated companies.  Achelous Partners provided investment banking and advisory services to RCA in the transaction. Learn more about Regulatory Compliance Associates at https://www.rcainc.com/.

 

Media Contacts:

Sotera Health:                                                                             

Kristin Gibbs                                                                                 

Chief Marketing Officer                                                            

kgibbs@soterahealth.com           

 

Regulatory Compliance Associates:

Erika Porcelli

Chief Executive Officer

E.Porcelli@rcainc.com

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Pleasant Prairie, WI (Sept 22, 2020) – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Steven Lynn has accepted the position of Executive Vice President of Pharmaceuticals.

 

Mr. Lynn brings more than  20 years of global, real-world experience in the private sector and U.S. federal government, including two U.S. Food and Drug Administration product Centers (the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health), as well as FDA’s inspectorate (the Office of Regulatory Affairs).  “RCA clients will benefit from Steve’s expertise with FDA’s insights regarding compliance and regulatory framework and will help them navigate regulatory challenges in the medical product and biologics sectors,” says Erika Porcelli, CEO of RCA.

 

In addition to his FDA experience, Steve gained valuable real-world, private sector experience in global manufacturing and quality for generics and brand pharmaceuticals, as well as in the medical device industry. Prior to joining RCA, Steve held executive roles with leading brand and generic pharmaceutical and biopharma manufacturers, the FDA, and in private consulting in the areas of pre and post-market (GxP) quality, compliance, and regulatory affairs.  “His extensive background spanning industry, consulting and the FDA gives Mr. Lynn a unique perspective in providing RCA clients with wholistic and seasoned guidance as they bring new life-sustaining medicines to the market, as well as maintaining compliance with FDA and other global health authorities quality oversight,” adds Porcelli.

 

Accomplished in leadership and quality management, Steve earned a Master of Science degree in Quality Systems Management from the National Graduate School of Quality Management (NGS), is a Senior Fellow in Study Excellence in the Excellence in Government Leadership Program, and has a Bachelor of Science degree in Biology.  Mr. Lynn also served the non-profit Parenteral Drug Association (PDA) as the Secretary of the Board.

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide 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-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

PLEASANT PRAIRIE, Wis.Nov. 25, 2019 – Regulatory Compliance Associates® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces Erika Porcelli has accepted the position of Chief Executive Officer.

 

“Bringing more than 20 years’ experience in relationship building, Erika’s focus for 2020 is centered on the customer experience,” said Board Chairman, Mitch Januszewski. “Erika brings a wealth of experience and energy to the company. We are looking forward to Erika’s client-focused leadership and the roll-out of client-centric initiatives in the new year.”

 

“More than ever before, we will be focusing on building relationships and putting our clients first,” said Porcelli. “We will be introducing new tools and processes to both streamline and deepen our client communications and ensure we’re consistently delivering the greatest value.” Having touched all aspects of RCA services, it’s these relationship-driven interactions that Porcelli values most.

 

Prior to her role as CEO, Erika Porcelli served as Senior Director of Business Development for RCA’s northern U.S. territory and, most recently, Vice President of Client Relations. She brings her extensive knowledge in marketing programs, analysis and market research, marketing communications, and sales process opportunities, as well as in-depth knowledge of the pharmaceutical, biotech, and medical device industries.

 

Additionally, she has expertise in new business development, contract negotiation, and budget management. Erika Porcelli is also the host of RCA’s podcast, RCA Radio, which launched in June 2019.

 

Erika Porcelli

 

About RCA

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide 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-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Warsaw, Poland – Regulatory Compliance Associates ® Inc. (RCA), a life sciences consultancy focused on quality, regulatory, and technical consulting, announces expansion into Europe with a new office in Warsaw, Poland.

 

Regulatory Compliance AssociatesRCA is currently headquartered in the USA with offices in Wisconsin, Colorado and Florida.

 

“We chose Warsaw as our next location, because it’s the heart of the Central Eastern European biotech industry. Having a presence in Poland uniquely positions Regulatory Compliance Associates to assist pharmaceutical, medical device, and biologics companies in devising and implementing strategies for approval in the global marketplace, particularly FDA and European Union,” says Mitch Januszewski, founder and principal of the firm.

 

Januszewski adds, “One of the first activities for our Warsaw office is to participate in BioForum 2014, the Central European Forum of biotechnology taking place in Lodz, Poland on May 28-29, 2014. We’re proud to sponsor conferences that advance the life science community.”

 

About RCA

 

Regulatory Compliance Associates® Inc. (RCA) provides worldwide 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-and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

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