Services: Strategic Consulting-Device

For Medical Device Industry

Mergers and Acquisitions / Due Diligence

Many companies move forward on medical device deals without a clear picture of their risks. A due diligence process that’s too high-level or superficial is often to blame. And, when a deal doesn’t deliver value, the real causes are often strategic, cultural, or technical. Regulatory Compliance Associates® Inc.’s worldwide experience in the evolving specialty of Mergers and Acquisitions can help ensure a successful mix of people and product, so you’re never embroiled in a costly mistake.

 

Our Mergers and Acquisitions services include:

 

  • Mergers and Acquisition Support
    • Regulatory Due Diligence
    • Quality Due Diligence
    • Facility / Equipment Assessment
    • Personnel Assessment
    • Post-Merger Integration

 

RCA can provide Strategic Consulting and services in the following key areas:

 

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. You may also email us at [email protected].

 

Risk Management: Mergers & Acquisitions

Getting the most value out of Mergers or Acquisitions requires proper upfront legwork, risk management and risk assessment.

 

risk managementIn the business press, discussions of mergers and acquisitions (M&As) invariably include percentages of deals that did not create their expected value. Failure numbers, ranging from 60–80%, are surprisingly high. Many companies seem to pursue mergers or acquisitions without a clear picture of their potential risks. A due-diligence process that’s too high-level or superficial is often to blame.

 

For example, when a life-science company considers a merger or acquisition, the due-diligence team typically looks for 483s, Warning Letters, notified-body findings, and product recalls to find any signs of potential problems with FDA. But when a deal does not deliver value, the real causes are often strategic, cultural, or technical.

 

Risk Assessment

 

Due diligence is not the same as risk management or conducting a quality assurance compliance audit. But in the life-science industry, it’s easy to confuse the two. The executives or the private-equity firm structuring the deal do not necessarily understand the companies’ operations or FDA sanctions.

 

At the same time, if a CEO or CFO is enamored with M&As as a perceived means to expand into a new business or enter a new market, the due-diligence team typically lacks the business expertise to ask the right questions or the clout to raise objections.

 

Risk Assessment Example

 

For example, Company A might want to buy Company B because of its superior sales force. Company A’s marketing department contends that sales would double; the finance department believes that redundancy would allow Company A to reduce payroll by 10%.

 

Both predictions are correct, but no one calculates the extra manufacturing capacity needed to produce a larger portfolio and volume of products. The expected value of the deal could be canceled out by unanticipated costs in another part of the organization.

 

Level of Compliance

 

The fundamental questions asked during due diligence should go beyond FDA compliance and tackle the business reasons for closing the deal. This approach requires having the right people (not necessarily those who happen to be available) on the due-diligence team.

 

Technical executives might be asked about open citations, but they’re rarely consulted about the likely costs of integrating factories, supply chains, or distribution centers—or whether these integrations can be done at all. But if integration costs more or takes longer than expected, customer relationships and product quality can suffer.

 

Checklists for Due Diligence

 

Often in a merger or acquisition, using a checklist to gouge the personalities of the two companies are not considered relevant. But stress and tensions can build when the cultures of two organizations are incompatible. The possible triggers of a poor “culture fit” are limitless: management style, risk tolerance, flexibility, talent, technology, and geography, to name a few.

 

Some life-science companies are risk-takers; others are conservative. Some are entrepreneurial; others are hierarchical. Some are obsessed with “zero incidents” quality; others have a “find a problem, fix a problem” management style. If the two cultures can’t be blended, the cost of a significant restructuring (including recruiting and hiring new executives) needs to be included in the M&A price tag.

 

Technology Due Diligence

 

Post-M&A integration is often the cause of extra, unplanned costs. For instance, a seller often ends up supporting sold-off processes or IT systems long after the deal is done. When this happens, the buyer can end up with a poorly managed function, and the seller can end up with disgruntled clients and extended costs. The deal’s stakeholders, each with different goals and agendas, need to talk to each other. External stakeholders can also be drawn into the due-diligence process to reduce such risks.

 

Transition services agreements (TSAs) should be drawn up carefully to protect buyers and sellers from value destruction. For the buyer, a TSA might specify that the seller’s employees will be available to talk to regulatory authorities during the integration time period. For the seller, the TSA might detail roles and responsibilities for the sold business or division. A key executive or consultant should ensure that TSAs are followed and that the buyer takes over on schedule.

 

Commercial Due Diligence

 

Any life-science company considering a merger or acquisition should consider the following five steps to ensure that its due-diligence process helps manage business risks and prevent value destruction.

 

FDA Compliance

 

Put the right people on the team. You have to be compliant with your notified bodies at any moment in time. A life-sciences company typically has multiple locations, some in other countries, as well as complex supply-and-distribution operations. The time available to understand compliance while making the deal value can be short. The due-diligence team therefore should be structured to quickly obtain real-world answers to fundamental questions.

 

This means including experts who can look at limited data and draw reasonable conclusions about areas such as: manufacturing, product portfolios, supplier relationships, IT capabilities, R&D and engineering, marketing and sales, and environmental compliance. A quality assurance specialist cannot cover all this ground alone. Perhaps most important, the team needs a senior executive who has the power to champion the right answer for the deal, even when that answer is “no.”

 

Risk Analysis Process

 

Consider the following example. A US company wanting to acquire a high-growth product line made a play for a successful company headquartered in Australia. The rewards matched the company’s objectives: revenue from sales outside the US would jump from 15 to 40%.

 

However, the risks would be just as great: registrations and patents would require global management, and the success of the venture depended on keeping the seller’s key people and infrastructure.

 

Technical Risk Assessment

 

The-due-diligence team included the COO as well as senior people from manufacturing, finance, legal, quality assurance, business development, and R&D, and an independent consultant to question assumptions. In addition to working with a virtual data room, the team spent two days interviewing seven of the seller’s top executives and one day touring the main production facility.

 

The team included a senior executive who would be in charge of the postmerger integration crucial to future revenue and earnings. Because the due-diligence team had the right people, the process contributed significantly to the immediate and long-term success of the acquisition.

 

Risk Evaluation

 

Ask the right questions. In many ways, due diligence is a detective’s game: the analysts need to look at clues (often from only partial data) and solve the mystery by defining the business case for the merger or acquisition, identifying the ways each facility or function would contribute to (or detract from) the realization of the business benefits, and pinpointing risks to processes, functions, or the enterprise. Even companies that do a lot of deals are wise to treat each one as a new and unique experience.

 

Find weak spots and define fixes. The due-diligence team needs to address areas of risk management, such as the costs and efforts required to harmonize operations, the timetable for fixing problems, and the investment needed for postmerger integration. For example, upgrading an acquired company’s enterprise resource planning system would be expensive and resource-consuming; its costs should be acknowledged.

 

Hazards Assessment

 

Use facts to negotiate. The financial decision makers want to know of any issue large enough to stop the deal. But even problems that are not dealbreakers could be used in negotiations. The due-diligence team needs to be prepared to talk to C-suite executives, bond-rating agencies, investment bankers, and the sellers about issues, potential solutions, a course of action and as its timing and estimated price tag.

 

Regulatory Compliance

 

Bring in the regulators early. The postdeal organization should inform FDA or other appropriate regulators of plans to fix recognized problems. Regulators know that M&As can create confusion and inconsistencies, and they look for them during inspections. Even if there are no risk management problems, it is a good idea for the buyer to connect with regulators to help ensure a smooth transition. Due diligence is a strategy for risk management and return on investment. When done right, it helps ensure value creation in a merger or acquisition.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

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

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • 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 pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting 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 regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

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

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 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. 

 

Life Science Due Diligence

Due diligence in a sentence is often mergers or acquisitions (M&A) when a team invariably did not realize the expected value creation. Failure numbers, ranging from 60-80 percent, are surprisingly high. Clearly, many companies move forward on medical device or pharma deals without a clear picture of their risks.

Due Diligence Process

A due diligence process that’s too high-level or superficial is often to blame. For example, when a life sciences company considers a merger or acquisition, the due diligence team typically looks for 483s, Warning Letters, notified body findings, and product recalls—any signs of potential problems with the FDA. But when a deal does not deliver value, the real causes are often strategic, cultural, or technical.

Financial Due Diligence

Financial due diligence is not the same as a QA compliance audit. But in the life science industry, it’s easy to confuse the two. The executives or the private equity firm structuring the deal do not necessarily “get” the companies’ operations or understand FDA sanctions. At the same time, if a CEO or CFO is enamored with M&A as a perceived means to expand into a new business or enter a new market, the due diligence team typically lacks the business expertise to ask the right questions or the clout to raise objections.

Manufacturing Capacity

For example, company A might want to buy company B because of its superior sales force. Marketing contends that sales would double; finance believes that redundancy would allow company A to reduce payroll by 10 percent. Both functions are persuasive within their own checklists for due diligence, but no one calculates the extra manufacturing capacity needed to produce a larger portfolio and volume of products. The expected value of the deal is cancelled out by unanticipated costs in another part of the organization.

FDA Compliance

The fundamental questions asked during the due diligence process should go beyond FDA compliance and tackle the business reasons for doing the deal. That requires having the right people (not necessarily those who just happen to be available) on the due diligence team from the beginning. Technical executives might be asked about open citations, but they’re rarely consulted about the likely costs of integrating two factories, or two supply chains, or two distribution centers—or whether these integrations can be done at all.

Product Quality

But if integration costs more or takes longer than expected, customer relationships and product quality can suffer. The due diligence team has to include people who can put the business case (or cases) to the test.

 

Need regulatory due diligence help? Talk to our Experts →

 

Commercial Due Diligence

Often in a merger or acquisition, commercial due diligence doesn’t gauge the “personality” of the two companies. Metrics often trump touchy feely considerations, especially when both organizations are successful in their own ways. But just imagine the stresses—to people and processes—if the cultures of two organizations are incompatible.

Organized Culture

The possible triggers of a poor company culture are nearly limitless: management style, risk tolerance, flexibility, talent, technology, and geography, to name a few. Some in life sciences are risk-takers; others are conservative. Some are entrepreneurial; others are hierarchical. Some are obsessed with “zero incidents” quality; others have a “find a problem, fix a problem” management style. These types of cultural incompatibilities are expensive.

Restructuring

If the two cultures can’t be blended, the cost of a significant restructuring (including recruiting and hiring new executives) needs to be included in the M&A price tag. The deal’s stakeholders, each with different goals and agendas, need to talk to each other.

Operational Due Diligence

Post-M&A integration is often the cause of extra, unplanned due diligence reporting. For example, a seller often is stuck supporting sold-off processes or IT systems long after the deal is done. When this happens, the buyer can end up with a poorly managed function, and the seller can end up with disgruntled people and extended costs. The deal’s stakeholders, each with different goals and agendas, need to talk to each other. External stakeholders can also be drawn into the due diligence process to reduce this risk.

Regulatory Authorities

Transition services agreements (TSAs) should be drawn up carefully to protect buyers and sellers from value destruction. For the buyer, a TSA might specify that the seller’s people will be available to talk to regulatory authorities during the integration time period.

Regulatory Due Diligence

For the seller, the TSA might detail roles and responsibilities during the regulatory due diligence for the sold business or division. A key executive or consultant should be put in place for the seller to assure TSAs are followed and that the buyer takes over on schedule, ending the seller’s responsibilities.

Technology Due Diligence

Any life sciences company considering a merger or acquisition should take these five steps to ensure that the technology due diligence due diligence process helps manage business risks and prevent value destruction.

1. Put the right people on the team.

A life sciences company typically has multiple locations, some in other countries, as well as complex supply-and-distribution operations. Also, the time available to draw up an offer can be as short as two or three weeks. The technology due diligence team should be structured to be quick in getting real-world answers to fundamental questions.

Quality Assurance

This means including experts who can look at limited data and draw reasonable conclusions about many different areas: manufacturing, product portfolios, supplier relationships, IT capabilities, R&D and engineering, marketing and sales, and environmental compliance. A QA specialist can’t cover all this ground alone. Perhaps most important, the team needs a senior executive who has the power to champion the right answer for the deal, even when that answer is NO GO.

Infrastructure

A US company wanting to acquire a high-growth product line made a play for a successful company headquartered in Australia. The rewards matched the company’s objectives: revenue from sales outside the US would jump from 15 to 40 percent. However, the risks would be just as great: registrations and patents would require global management, and the success of the venture depended on keeping the seller’s key people and infrastructure.

Manufacturing Plant

The technology due diligence team included the Chief Operating Officer, as well as senior people from manufacturing, finance, legal, QA, business development, R&D, and an independent consultant to question assumptions. In addition to working with a virtual data room, the team spent two days interviewing seven of seller’s top executives and one day touring the main production facility.

Management Information Systems

Last, but certainly not least, the team included a management information systems executive who would lead the post-merger integration critical to future revenue and earnings. Because the due diligence team had the right people, the process was able to contribute significantly to the immediate and long term acquisition success. The due diligence team should be structured to be quick in getting real-world answers to fundamental questions.

2. Ask the right questions.

In many ways, technology due diligence is a detective’s game: the analysts need to look at clues (often from only partial data), and then solve the mystery by defining the business case. Technology should help identifying the ways each facility or function would contribute to (or detract from) the realization of the business benefits, and pinpointing process risks, functions, or the enterprise. Even companies that do a lot of deals are wise to treat each one as a brand new and unique experience.

3. Find weak spots, and then define fixes.

The technology due diligence team needs to address areas of risk, such as the costs and efforts required to harmonize operations, the timetable for fixing problems, and the investment needed for postmerger integration. For example, upgrading an acquired company’s ERP system would be an expensive and resource-consuming project; its costs should be acknowledged.

4. Use facts to negotiate.

The financial decision makers want to know of any issue large enough to stop the deal. But even those problems that are not deal breakers could be used in negotiations. The technology due diligence team needs to be prepared to talk to C-suite executives, bond rating agencies, the investment bankers, and the sellers about issues, potential technology gaps and a course of action with estimated price tag.

5. Bring in the regulators early.

The post-deal organization should inform the FDA or any other regulators of plans to fix recognized problems. Regulators know that a merger or acquisition can create technology confusion and inconsistencies, and they look for that during inspections. Even if there were no problems, it would still be a good idea for the buyer to be proactive in connecting with regulators to help ensure a smooth transition.

Due diligence is a strategy for risk management and return on investment. When done right, it helps assure value creation in a merger or acquisition. Going beyond compliance during due diligence is the key to successful M&A. Even those problems that are not deal breakers could be used in negotiations.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

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

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • 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 pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting 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 regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

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

 

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science 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 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 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. 

 

 

Portfolio Risk Management

Client

Middle-market private equity firm in need of risk management support

Target

Pre-revenue portfolio company

Industry

Pharmaceutical

Business Challenge

Conducting a new product development assessment for a portfolio company

Project Timeline

Pre-launch research & target product profile development – 6 months

Internal implementation of portfolio risk matrix – 3 months

Commercial pipeline analysis – Ongoing

 

Private Equity Challenge

A global private equity firm based in the United States approached RCA to conduct a new product development assessment for a portfolio company. The client eeded industry expertise based on preclinical commercial opportunities in the pipeline and category metrics from the internal product management team. The client also had a need for a voice-of-business research study to be conducted to understand employee attitudes about the key drivers set in place by the commercialization team. Finally, the middle-market PE firm needed data to set a longer-term acquisition strategy based on channel potential and potential acquisition targets that made the most sense for the portfolio.

 

RCA Approach

Qualitative information was used to create a multifactor risk assessment to determine each target product profile and the perception of risk. The assessment included the following key requirements:

  • Business strength factors were ranked by employees who compared key attributes across intended product profiles (e.g. product differentiation, brand equity, etc.)
  • Market attractiveness factors were ranked by employees who compared key attributes across intended product profiles (e.g. market size, competitive forces, etc.)

Voice-of-business research was then conducted to populate the risk assessment. Data was collected through employee responses based on the perspective of product profiles, business strength, and market attractiveness factors.

 

Private Equity Results

Perception mapping and matrix-style results were presented to the client team after all team members completed their voice-of-business survey. Results were weighted across all factors based on team inputs, the importance of strategic factors in relation to other factors, and employee expertise of their specific product category.

RCA discovered many unique data points for consideration by the portfolio company and private equity firm from the risk assessment:

  • The business strength of the preclinical product alternatives were ranked higher than previously anticipated.
  • Market growth rate was perceived to make a greater impact on future sales than current market size.
  • Competitive rivalry in the channel was the greatest risk management factor by the portfolio leadership team. This included a lack of awareness of disruption potential in the channel or the threat of new category competition.
  • Government regulatory environment was consistent across the model due to the compliance-based nature of the life sciences industry. However, power of existing channel partners showed in the data analysis as a differentiator when it came to who could influence the regulatory speed-to-market.

The client team developed talking points for the Board of Directors based on this analysis:

  • Opportunities that were previously considered a secondary priority (e.g. smaller profit margin potential in large sales channels) were to be reassessed based on the sales channel potential.
  • When the cost of capital to develop a preclinical product was held constant across the risk management model, technology and innovation costs quickly escalated.
  • One of the preclinical products achieved a higher score based on the strategic partner in place who could assist commercialization and market sales.
  • Macro-environment change and potential for channel disruption were determined to be decisive gaps for both the private equity firm and portfolio company.

 

Private Equity Takeaways

  • An internal risk management council was established by the Board of Directors to consider how unknown channel disruption may impact their portfolio risk or future new product introductions.
  • Business strength factors signaled the anticipation of success as a pre-approval product portfolio. This was important to the PE firm and portfolio company as a positive indicator even though commercialization lagged behind the existing entrants and competitors.
  • The market growth rate analysis helped the PE firm to recalibrate leadership guidance that pursuing slower CAGR markets larger in size remained just as important as faster growing channels.
  • Portfolio company leadership added additional product management headcount to address the lack of understanding of disruption potential and new category competition.
  • The emerging importance of technology and innovation from the assessment results led to a new project where the portfolio company began examining leveraging manufacturing automation and big data.
  • Recognizing the importance of channel partner strength led the PE firm to reconsider their portfolio bolt-on strategy with existing channel partnerships as a higher priority in targets being considered.

 

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 Single Audit Program (MDSAP)

MDSAP is a standardized global auditing program which allows for a single regulatory audit of a medical device manufacturer’s quality management system (QMS) to be conducted to satisfy the requirements of several global regulatory agencies and/or regulatory bodies. 

MDSAP was conceived in 2012 (launched in 2014) by the International Medical Device Regulators Forum (IMDRF).  The program officially completed the pilot phase in December of 2016 and manufacturers are now able to begin the process for certification.  Currently 5 countries are participating in the program and they include: USA, Canada, Australia, Brazil and Japan.  The World Health Organization (WHO) and the European Union (EU) are Official Observers.  One special area of consideration is that manufacturers selling products in Canada have a deadline of January 1, 2019 to become certified in order to continue to sell their products on the Canadian Market. MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) in Canada. The two (2) year transition period in Canada started on January 1, 2017 and continues through January 1, 2019. At the end of this transition period, only MDSAP certificates will be accepted. 

 

Global Regulatory Authorities Designated Use of the MDSAP Audit Reports
US – FDA The FDA will accept the MDSAP Audit Report in lieu of FDA routine inspections.However, MDSAP does NOT apply for certain types of regulatory inspections including:·         “for cause” inspections·         “compliance follow-up” inspections; or·         pre-or post-approval inspections for PMA (Premarket Authorization)
Canada – HC MDSAP will replace the Canadian Medical Device Conformity Assessment System (CMDCAS) by the end of the (2) two year transition period in Canada [January 1, 2017 to January 1, 2019]. After the transition period ends in Canada, only  MDSAP certificates will be accepted.
Australia – TGA MDSAP Audit Reports may be used to support compliance with the medical device authorization requirements (unless the particular medical device is excluded or exempt from the requirements)
Brazil – ANVISA MDSAP Audit Reports may be used to support the technical evaluation of the premarket and post-marketing requirements.
Japan – MHLW and PMDA MDSAP Audit Reports may be used to support the premarket and postmarket requirements.

 

MDSAP audits must be conducted by recognized Auditing Organizations (AO) authorized by the participating global regulatory agencies and/or regulatory bodies pursuant to the MDSAP requirements.  These will be conducted on an annual basis based on a (3) three year certification cycle.

 

What to expect in the MDSAP audit:

During your MDSAP audit, you should expect the Auditing Organization to cover all elements of ISO 13485 (Management, Device Marketing Authorization, Measurement and Analysis, Medical Device Adverse Events Reporting, Design and Development, Production and Service Controls, and Purchasing) with a heavy emphasis on:

  • Incorporation of risk within all processes to manage your product lifecycle
  • More scrutiny on your outsourcing practices
  • Both design and process validation
  • Design change management and risks associated with these changes

 

Value Proposition

Traditionally, manufacturers selling their products globally were faced with the challenge of being audited by multiple regulatory authorities causing disruption to manufacturers.  MDSAP evolved because it was recognized that a single audit would be more efficient while ensuring the Quality Management System was thoroughly covered during an audit.  It also provides consistency in the audit process and minimizes the burden on resources.  All important factors when you consider efficiency goals within an organization.

 

What’s in it for the Regulatory Authorities?

  • Creates a coalition of countries utilizing shared technology, resources, and services to improve the oversight of medical devices more efficiently.
  • Better utilizes the widely accepted international standards and best practices to achieve alignment of regulatory approaches of multiple regulatory bodies.

 

What’s in it for the manufacturer?

  • One audit overall instead of one per Regulatory Authority means less burden on manufacturer resources to deal with multiple audits.
  • Use of standardized non-conformity grading system will make the outcomes more predictable.
  • Utilization of a consistent audit criteria compliant to the requirements of all participating regulatory authorities will be used by the Auditing Organizations.
  • Saves you time and money by participating in 1 audit versus multiple audits.

 

Country specific Adverse Event Reporting

  • In 2012 Australia made access available to the Database of Adverse Event Notifications (DAEN). The database is searchable by report number, date, manufacture, sponsor, etc. 
  • The Manufacturer and User Facility Device Experience (MAUDE) has been available since 1996 and is also searchable by report number, date, manufacturer, etc. The product problems are categorized into more than 1,000 device and patient problems as defined by Code 3500A
  • Canada utilizes what is referred to as the Adverse Reaction Database. The search criteria is more limited however, reports date back to 1965.
  • Japan and Brazil also have information available publicly however, the incidents are only available in the local languages.
  • European Database on Medical Devices (EUDAMED)*
    • EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission’s Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC and 2000/70/EC.
    • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.
    • EUDAMED will also develop a vigilance module. This vigilance module will inform Member States on incidents or near-incidents in relation to certain devices on the market.

*Note, EUDAMED is expected to be operational in March of 2019.  Note this date is subject to change.

 

About RCA’s Medical Device Consulting Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post-market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans, or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

Regulatory Compliance Associates Quality Assurance services include quality system assessments, strategy, implementations, 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.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates worldwide experience can help ensure a successful mix of people and products so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science 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. 

 

Product Life Cycle Management

Product Life Cycle Services

Product Life Cycle Management (PLM) is the systematic approach to effectively manage the series of changes your product may go through from its early concept phase through design and development, to commercialization, and ultimately up to the product’s end of life and/or obsolescence.

 

RCA’s approach to Product Life Cycle Management includes the application of different strategies to help meet the challenges you may face during the life cycle of your product(s).

  • Project Leadership
  • Prototype Development
  • Risk Analysis
  • Integration of Risk Mitigation into Product Development
  • Design Verification and/or Validation Test Protocols
  • Design Review Planning and Facilitation
  • Change Management
  • R&D Process Optimization for Increased Effectiveness and Efficiency
  • Design and Development Standard Operating Procedure Development
  • Regulatory Analysis and Filling Strategy Development
  • Design History File Compilation
  • Change Management
  • Design Enhancements
  • Obsolescence and End of Life Strategy and Implementation
  • Independent Product Verification and Validation

 

RCA can provide Strategic Consulting and services in the following key areas:

 

 

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. You may also email us at [email protected].