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Interphex 2023

Posted on by Brandon Miller

Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 25th–27th 2023 in Philadelphia with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

interphex

Regulatory Compliance Associates® Distinguished Fellow and the Parenteral Drug Association® (PDA) Chair of Board of Directors, Susan Schniepp, will be presenting a tech talk where you will learn more about contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and define preventive actions associated with contamination in sterile product manufacturing.

Sue is the knowledge leader for RCA® and is Chair of the Parenteral Drug Association (PDA) Board of Directors. Sue’s background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.

 

About Interphex® 2023

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.

interphexBased in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

About RCA’s Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

  • 21 CFR 210
  • 21 CFR 211
  • Data Integrity
  • Computerized System Validation
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About RCA®

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

Vice News Interview: Coronavirus Is Revealing Gaping Holes in America’s Drug Supply Chain

Posted on by Brandon Miller

Check out the interview Vice News did with our Executive VP of Pharmaceuticals, Steven Lynn, on how the Covid-19 pandemic is revealing major holes in the pharmaceutical supply chain.

 

About Steve Lynn

Supply ChainSteve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.

Joining Regulatory Compliance Associates® Inc. in September of 2020, Steve serves as RCA’s Executive Vice President of Pharmaceuticals.

Prior to joining RCA, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a compliance and supply chain consultant. He was the Global Head of Group (Corporate) Compliance and Audit for Novartis AG. In this role he led the corporate-level GxP corporate compliance and audit functions across the company.

Next, Steve was the inaugural Vice President of Global Quality Compliance for Mylan, Inc. a large generics manufacturer. Prior to rejoining the private sector, Steve worked for nearly a decade at the FDA. At the FDA, was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role, he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs.

In addition, in his last year at the FDA, he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

Steve also served in two acting roles on the inspectorate side of FDA within the Office of Regulatory Affairs (ORA). First, he served as the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Immediate Office of ORA’s Office of Operations. In this role, Steve was responsible for advising the ACO in their role of leading and managing ORA’s Office of Operations, which is responsible for all of the Agency’s Headquarters, Domestic and Foreign Field Investigatory, Compliance, and Laboratory Operations.

Second, Steve served as the acting Director for ORA’s Office of Medical Products and Tobacco Operations (OMPTO). In this role, Steve represented and made decisions on behalf of the ACO relating to medical and tobacco product program investigatory operational issues, including emergency response activities and supply chain. In addition, he directed the coordination and management of all domestic and foreign Agency field operations related to medical (drugs, biologics, and medical devices) and tobacco products. Additionally, Steve served as the operational liaison for medical products and tobacco inspection programs to FDA’s medical product and tobacco Centers, as well as to the Agency’s foreign offices.

Steve received a Bachelor of Science degree in Biology from Bethany College in Bethany, WV, and a Master of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, Senior Member of the American Society for Quality (ASQ), and an Excellence in Government Program Senior Fellow.

 

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. 

Erika Porcelli Announced as Chief Executive Officer of Regulatory Compliance Associates® Inc.

Posted on by Brandon Miller

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. 

Sotera Health Announces Acquisition of Wisconsin-Based Regulatory Compliance Associates

Posted on by Brandon Miller

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. 

Regulatory Compliance Associates® Inc. Welcomes Steven Lynn as Executive Vice President of Pharmaceuticals

Posted on by Brandon Miller

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. 

Inshoring Strategy

Posted on by Brandon Miller

As with many industries these days, pharmaceutical manufacturers are now reevaluating the structure of their manufacturing operations. A specific focus area is whether returning some or all production processes to American shores (inshoring) is a more practical and cost-effective alternative to the offshoring trend that’s been prevalent for several decades. 

 

Are you Considering In-Shoring your Pharmaceuticals?  Talk to our Experts →

 

Factors That Impact the Inshoring/Off-Shoring Decision

Examples of crucial considerations when in-shoring pharma include:

 

Manufacturing

If yours is like many pharma operations, you chose to outsource due to the lower production and labor costs available overseas. If it’s been a while since you’ve compared manufacturing abroad vs. at home, consider conducting a comprehensive cost analysis. You might be surprised to learn that you can now produce a pharma product in the U.S. more cheaply than before. In some cases, the costs are now nearly as low as in China.

 

Suppose your manufacturing cost analysis yields favorable results and you determine to move forward with in-shoring. The next step is to decide the type of manufacturing facility that makes the most sense for your operation. Specifically, you should determine whether a brownfield (existing) or greenfield (brand-new) site is the better option. 

 

Technology

inshoringIf you’re evaluating an existing structure, take a look at the current equipment and technology. Are they compatible with your projects’ demands? If not, can you make cost-effective upgrades or modifications to bring them up to speed? If these hurdles are prohibitive, building a greenfield facility will likely provide a more practical and affordable long-term solution. 

 

A greenfield site enables you to customize your manufacturing processes more effectively since you are building and equipping the facility from scratch. On the downside, the costs of a new building, compatible machinery, and hiring and training fresh personnel may not be affordable for some pharma operations. And constructing a new facility from the ground up takes time — a commodity that’s often in short supply in today’s ultra-competitive pharma industry. 

 

Supply Chain

Supply chain access is another vital factor when in-shoring pharma operations. Given that many of the raw materials and ingredients used to manufacture pharma products and medical devices come from outside the U.S., finding acceptable substitutes at home can pose a challenge. If you must import them, you’ll need to consider the added transportation and costs of these components.

 

You’ll also need to account for all applicable supply chain qualifications. For instance, if you’re partnering with new suppliers, you must ensure they meet your company’s unique qualification and quality criteria. Transportation concerns are another issue to evaluate. Will you be able to get the materials to your facility reliably on time to accommodate your production schedules? You’ll need to implement a qualified transportation system for certain essential ingredients and finished goods. 

 

Operations

From a business/operational perspective, consider how in-shoring pharma will impact your personnel. For instance, if you decide to move into an existing facility, determine if there will be sufficient space for your workers and any new equipment you add. Also, can the facility accommodate essential areas such as clean rooms, warehousing, waste treatment systems, and cold storage spaces?

 

If you’re relying on outdated technology systems, you’ll likely need to make upgrades to meet the changes in demand. Examples of systems that require careful evaluation include ERP, CAPA management, and eDoc, to name a few. 

 

About RCA

inshoringRegulatory 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-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

 

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. 

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